Would You Restrict Carbs to Ease Diabetes Management? (ADA 2020)

Children and adolescents with type 1 diabetes are currently living at a time of a big diabetes technology boom. Continuous glucose monitors (CGMs) and insulin pumps are becoming more popular and offer the promise of better glycemic management and more freedom and peace of mind. As research and clinical trials on automated insulin delivery systems are in full-swing, clinicians from The Joslin Diabetes Center, Yale University, and Harvard University were interested in understanding various patient preferences. In one study, they posed the following question:

Would young people with type 1 diabetes be willing to limit their carbohydrate intake to a maximum of 50 g per meal if this meant they wouldn’t have to administer a manual bolus using an artificial pancreas (AP) system? 

The outcomes of this research were recently presented at the American Diabetes Association (ADA) 80th Scientific Sessions.

To help understand patient perspectives and preferences on this subject,  39 participants (average age 17 +/- 4.7 years) were recruited at two study centers. These patients had an average diabetes duration of 9.4 +/- 4.9 years and an average HbA1c of 8.4 +/- 1.1 %. Interviews were conducted with each participant and parents to gauge their views on the willingness to “limit carb intake to 50 g per meal/snack if this would eliminate the need to manually bolus for food when using the AP system.”

Based on their analysis, the study authors derived the following major insights:

  1. The majority of participants (and their parents) would prefer to have the option of eating more than 50 g per meal/snack and were willing to manually bolus for the excess carbs.
  2. Most believed that 50 g per meal or snack was too restrictive.
  3. Young people generally agreed that automation would “reduce self-care burden.”

The researchers concluded,

“An aversion to food restrictions overpowers the desire for an AP system that can independently manage glucose levels though limited carbohydrate intake. Carbohydrate limitations appear to increase self-care burden more than the time and effort expended on carb counting and bolusing. Future AP systems should consider options that enable users to choose to bolus manually for large meals and to forego bolusing for smaller ones.”

Here are a few notable quotes from the participants, which were highlighted in the poster presentation:

“I think that, if I had to choose between bolusing or limiting my carb intake, I think I would rather bolus, just because nobody really wants to be told what to do.” (25-year-old female)

“Every once in a while she wants to have an ice cream. You know, I think she should be allowed to have these things sometimes when she wants them. I don’t want her to be too restricted.” (Mother of a 16-year-old.)

Sadly, despite continuing advances in technology, the glycemic management for youth with type 1 diabetes has been stagnant or worsening, depending on the age group, for decades. As per the most recent available data, the average HbA1c for young people with type 1 is about 8.7%, similar to what was observed in this cohort. Automated insulin delivery could offer an important solution to so many young people who do not meet the ADA-set glycemic targets (currently, the organization recommends individualizing the A1c goals, from as low as <6.5% all the way up to <8% for some patients).

This study provides an interesting snapshot into what many young people with type 1 diabetes appear to consider very important — the freedom to eat whatever they want and bolus for it. 

There has been a long-standing debate, often in the diabetes online community, and sometimes among healthcare providers, about a low-carbohydrate approach for young people. Many have highlighted the benefits, and exceptional success stories. They are not just anecdotes, either. At least one study has demonstrated exceptional outcomes of carbohydrate lowering for youth with type 1 diabetes, with excellent adherence and reported quality of life, a normal average A1c of ~5.7%, and a very low rate of adverse events.

Nevertheless, some question difficulty of maintaining a lower-carbohydrate diet, and concerns have been cited over the potential for the development of eating disorders as a result of “restricted eating”.

When it comes to developing AP systems, this study suggests that many young patients would prefer more flexibility in the upper threshold of their carbohydrate intake and are willing to put in the work to manually bolus for and accept the outcomes, whatever they may be, of higher carbohydrate eating patterns, in lieu of sticking to a recommended carb limit and not having to manually deliver their insulin dose. Of  course, this is just a small study, and the results may be skewed towards this perspective due to the predominance of teenagers in this cohort. Also, it may be interesting to evaluate a shift in this perspective, if any, following a formal diabetes education program to explain to patients and parents, in detail, the benefits of lowering carbohydrate intake for diabetes management in general, and in the context of AP technology.

What are your thoughts on the subject? We love hearing from our readers.

Source: diabetesdaily.com

Research Shows High Blood Sugar Can Cause Brain Damage (ADA 2020)

New research presented at the American Diabetes Association (ADA) 80th Scientific Sessions last month revealed some startling potential consequences of hyperglycemia on brain function. Scientists from the University of California, Los Angeles, applied brain imaging and specialized analysis techniques to discern differences in the brain structure of patients with type 2 diabetes at different levels of HbA1c, along with nondiabetic control subjects. The work was funded by the National Institutes of Health/ National Institute of Nursing Research.

Study Design

A total of 49 patients with type 2 diabetes were enrolled in the study (12 controls, 22 with A1c>7%, and 15 with A1c<7%). The demographic information is summarized below.

For all subjects, magnetic resonance imaging (MRI) was used to gather images of the brain, and the “whole-brain mean diffusivity (MD)”, a measure related to certain brain functions, was assessed and compared between the three groups.

Study Outcomes

The main outcome of the study was as follows:

“Uncontrolled T2DM patients showed increased MD values in multiple brain areas, including the cingulate, insula, para-hippocampal, hippocampus, cerebellum, basal-forebrain, prefrontal, frontal, and temporal cortices over controlled T2DM patients and healthy controls.”

The study authors went on to explain that the brain regions that showed significant tissue damage are known to involve various aspects of cognition, including mood.

Conclusions

The main implications of this study are as follows:

  • Higher A1c levels are associated with higher likelihood of brain damage
  • The areas of the brain that are likely to be affected serve to regulate various cognitive aspects, including mood

Furthermore, the study authors noted that the brain injury incurred due to hyperglycemia may further hinder the patients’ ability to manage their blood glucose levels effectively. In the clinical implications discussed in their poster, the researchers concluded,

“Poor glycemic control is associated with increased brain injury. Brain injury is located in regions which can impair diabetes self-care. Patient education which require these brain regions may not be effective. If confirmed, brain protection should be considered as a benefit of good glycemic control in clinical discussions with T2DM patients”

While this work provides important insights into how persistent hyperglycemia may negatively affect cognitive function, it will need to be further validated through additional research. Also, as this study was performed on a cohort of patients with type 2 diabetes only, it is not clear at this time whether these findings may be relevant for those with type 1 diabetes, although it is logical to postulate that glycemia is the primary determining factor in these findings.

Source: diabetesdaily.com

Debate: Should the Artificial Pancreas Include Glucagon? (ADA 2020)

For the millions of people living with type 1 diabetes worldwide, the development of an effective system to automatically regulate blood sugar levels is of paramount significance. Artificial pancreas systems (APS) are being developed with the goals of automatically adjusting the delivery of insulin (and potentially, glucagon) based on glucose readings from a continuous glucose monitor (CGM), taking a lot of burden off patients, improving glycemic management, and enhancing safety.

What is the best way to approach the design of an artificial pancreas system? What are the pros and cons of including glucagon in the system alongside insulin?

Two experts debated this important issue at the American Diabetes Association (ADA) 80th Scientific Sessions last month.

Dr. Roman Hovorka, PhD, FMedSci from the University of Cambridge, argued against the inclusion of glucagon in the system, while Dr. Steven J. Russell, MD, PhD from the Massachusetts General Hospital, presented his case to support the use of a dual-hormone system. Both speakers disclosed several relationships with diabetes technology companies (including those working to develop APS).

Here is the summary of this interesting debate.

The Case for Single Hormone

Dr. Roman Hovorka highlighted some research outcomes of artificial pancreas systems that utilize insulin alone.  He presented data from several studies showing that these devices “improve time in target and time below target” as well as reduce A1c. However, the time in target range was only increased by ~11%, and the A1c improvements were modest, with the average A1c still above the ADA recommendations.

Dr. Hovorka explained that the vast majority of companies are currently moving forward with single-hormone systems. He also focused on a system developed by Cambridge that he’s very familiar with, showing data where ~95% time-in-range (TIR) was achieved. Notably, he remarked that a low-carb diet was also an important factor in this success case. Overall, however, only 7% of users were shown to achieve a time-in-range metric of >90%, although 28% achieved a TIR of >80%, 69% achieved a TRI >70%, and 86% achieved a TIR of >60%.

The presenter noted that one of the main issues currently hindering the efficacy of the APS is the delayed insulin absorption and action after subcutaneous insulin delivery. Adding glucagon into the system will not fix the issue, he noted, as “dual hormone delivery DOES NOT accelerate insulin absorption.”

While he acknowledged that glucagon could be useful in reducing low blood sugar risk in such systems, he also highlighted the complexity and high cost of such a system as barriers. In addition, he noted that the use of two separate cannulas could be burdensome, and for children, in particular. He also noted that the chronic delivery of glucagon subcutaneously requires more research to identify any risks.

In comparing the outcomes between single-hormone vs. dual-hormone systems, Dr. Hovorka noted that there was a slight increase in the TIR for the dual system (~78% vs. 71% in the longest studies), and the mean glucose (156 mg/dL vs. 140 mg/dL) was lower for those using the dual system. He also presented data to indicate that daytime hypoglycemia (in particular during exercise) could be reduced using a glucagon-insulin system, while a single insulin system was enough to eliminate hypoglycemia overnight. Furthermore, “comparative benefits of the single- and dual-hormone systems for improving HbA1c and preventing severe hypoglycemia remain unknown,” he underscored.

The Case for Dual Hormone

Dr. Steven Russell noted first that he believes “insulin-only hybrid artificial pancreas systems are the state-of-the-art in diabetes care” and that he is involved with projects that utilize both single- and dual-hormone approaches. Next, he went on to explain why he thinks a dual-hormone system would be more appropriate.

After pointing out that there are actually two hormones that are missing in type 1 diabetes – insulin AND glucagon, he suggested that in addition to further preventing hypoglycemia, a dual-hormone system can also help achieve lower average glucose and higher TIR than an insulin-only system. He presented several studies to support this point, including recent data from his project.

Importantly, Dr. Russell pointed out that by using micro-doses of glucagon to prevent or treat hypoglycemia could “oppose weight gain or encourage loss”. This is because using glucagon instead of carbohydrates to prevent or treat low blood glucose “promotes satiety and increases energy expenditure”.

While the speaker acknowledged the challenges associated with developing a dual-hormone system, he also noted that recent work has been bringing us closer to achieving this feat effectively. For instance, a number of stable glucagon formulations are now available (although not yet FDA approved for use in such a system). The safety studies that have been conducted have been reassuring.

Moreover, Dr. Russell addressed a common concern of glycogen store depletion, citing a 2015 study that indicated “no significant decrement in liver glycogen after repeated glucagon doses”. Importantly, he also presented some research showing that “users prefer the bi-hormonal system”, especially among those who aim for lower targets.

When addressing the potential increase in cost for a dual-hormone system, Dr. Russell had this to say:

“[The] significant increase in beneficial outcomes will justify the increase in cost… The difference in having no automation to single-hormone artificial pancreas is the same increment as you get going from a single-hormone artificial pancreas to dual-hormone… If one can justify adding automation, one could justify some additional expense to add the cost of the glucagon…”

Conclusions

Numerous artificial pancreas systems are currently being developed, with the vast majority opting for the insulin-only version. No doubt, the specific algorithms and insulin types used also play a paramount role in their efficacy and patient satisfaction. The use of glucagon remains a point of contention.

What are your thoughts on the subject?

Source: diabetesdaily.com

The Biggest News in Diabetes Technology, Drugs, and Nutrition: Highlights from ADA 2020

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler, Jimmy McDermott, Matthew Garza, Divya Gopisetty, Frida Velcani, Emily Fitts, Karena Yan, Joseph Bell, and Rosalind Lucier

The diaTribe team attended the 2020 ADA 80th Scientific Sessions to share several of the greatest highlights from the virtual conference!

The American Diabetes Association (ADA) 80th Scientific Sessions was full of exciting news on advances and studies in diabetes technology, treatments, and nutrition. Click on the links below to learn more!

Diabetes Technology

Diabetes Drugs

Nutrition, Exercise, and Mindset

Access to Care and Policy

Diabetes Technology

The Next Generation of Automated Insulin Delivery Systems for People with Type 1 Diabetes – Updates from Four New Clinical Trials

The first day of ADA featured data on four clinical trials of the newest automated insulin delivery (AID) systems. In what was a packed (virtual) room, the session began with three highly anticipated presentations of studies on Medtronic’s MiniMed 780G Advanced Hybrid Closed Loop System (AHCL). Dr. Bruce Bode, presented the US adult pivotal trial. Here are the main results:

  • Big news – nearly 80% of participants achieved a time in range of more than 70% without an increase in hypoglycemia.
    • On average, AHCL therapy increased time in range to nearly 75% from a baseline of 68.8%.
    • Among adolescents, time in range increased to over 72% from a baseline of 62.4%.
  • AHCL therapy improved average A1C from 7.5% to 7.0%. This is what is sometimes called a “high quality A1C” in the field – hypoglycemia is low, and therefore not contributing to a “better” number.
  • How were these results achieved? Experts said that the lower algorithm target of 100 mg/dl (vs. 120 mg/dl) helped, along with an active insulin time (AIT) setting of 2-3 hours. If you use a pump, check what you have for this setting and talk to your healthcare professional about it to see if you can make changes (regardless of whether your pump can deliver insulin automatically).

Following Dr. Bode, International Diabetes Center’s Dr. Rich Bergenstal shared data from FLAIR, a trial comparing MiniMed 780G Advanced Hybrid Closed Loop (AHCL) with the 670G Hybrid Closed Loop (HCL) in adolescents and youth with type 1 diabetes (ages 14-29). This is the first ever head-to-head comparison of an AID system with a commercially available AID system. The study also had broad entry criteria: at start, 20% of participants were on multiple daily injections of insulin (MDI), 38% were not using CGM, and 25% had a baseline A1C above 8.5%.

  • Time in range over 24 hours increased from 57% at baseline to 63% with the 670G and to 67% with the 780G. Notably, 6% greater time in range totals nearly an hour and a half more time in range per day.
  • Compared to baseline, the number of participants achieving the international time in range consensus target of more than 70% was nearly two times higher with the 670G and almost three times higher with the 780G (22% and 32% of participants, respectively, compared to a baseline of 12%; see slide below).
  • This was the first time that a study measured participants meeting the combined metric of both time in range greater than 70% and time below 54 mg/dL less than 1% (see slide below). This is important since all therapy – and particulary automated insulin delivery – aims to decrease hyperglycemia and hypoglycemia.

Graph

Image source: diaTribe

  • From a baseline average of 7.9%, those on the 670G achieved an average A1C of 7.6%, and those on the 780G had A1Cs that fell to 7.4% on average.
  • Both the 670G and 780G were considered safe when evaluating severe hypoglycemia or diabetic ketoacidosis (DKA).
  • Participants satisfaction favored the 780G over the 670G.

Today’s MiniMed 780G data finished with Dr. Martin de Bock’s study, which served as the clinical trial supporting 780G’s CE-Mark submission (and today’s announced approval in Europe). In a study of 59 people (ages 7-80 years, with an average age of 23) who had never used an insulin pump:

  • Average time in range increased to over 70% from 58% (a change of 12.5%) when using the 780G compared to a sensor augmented pump.
  • Overnight time in range increased to 75% from 59% when using the 780G compared to the sensor augmented pump.
  • The improvement in time in range was primarily driven by a 12.1% decrease in time in hyperglycemia (high blood sugar) with the 780G.

It was warming on Twitter to see Dr. de Bock with his three small children while also engaging in Q&A/Chat from their breakfast table. If you’re on social media, follow Dr. De Bock here.

The session concluded with Stanford’s Dr. Bruce Buckingham who presented data on Insulet’s Omnipod 5 Automated Glucose Control System, powered by Horizon. What fantastic data! The study assessed the safety and effectiveness of the fully on-body system over 14 days of use before starting the three-month pivotal study. Interestingly, this study was conducted during the winter holiday season when some of the lowest time in range is observed (typically a three percent drop); the system performed remarkably well in both children and adults, even during this challenging time period.

  • In adults, time in range increased to 73% on the hybrid closed loop system, up from 65.6% using standard therapy – this is the same as nearly two hours more time in range per day.
  • In youth, time in range increased to 70% on the hybrid closed loop system, up from 51% using standard therapy – what an increase, nearly five hours more per day.

These reductions in time in range were mostly driven by a decrease in hyperglycemia. Hypoglycemia was also very low to start. Dr. Buckingham eloquently emphasized, “… this is so important for families and people at night to go to sleep and not worry about hypoglycemia … for a number of kids, they got to go on their first sleepover during this study. It was really decreasing a lot of the burden and a lot of the thinking about diabetes.”

Tandem’s Control-IQ Real-World Data: Time in Range Increases 2.4 Hours Per Day

Tandem presented two posters featuring very positive real-world data from early Control-IQ users. Control-IQ was cleared in December 2019 and officially launched in January 2020.

The first poster, Control-IQ Technology in the Real World: The First 30 daysincluded at least 30 days of pre- and post-Control-IQ data from 1,659 participants. During the first 30-days of Control-IQ use:

  • Time in range increased by 2.4 hours a day (compared to pre-Control-IQ data) to 78%
  • The time in range improvement was driven by a 9.5% decrease in time spent above 180 mg/dl (that’s 2.3 hours less per day in hyperglycemia – wow!).
  • Average glucose levels fell from 161 mg/dL to 148 mg/dL.
  • Glucose management indicator (or GMI, an estimate of A1C) fell from 7.2% to 6.9%.
  • Users spent 96% of time in closed loop!
Teplizumab graph

Image source: diaTribe

The second poster, Glycemic Outcomes for People with Type 1 and Type 2 Diabetes Using Control-IQ Technology: Real-World Data from Early Adopters, looked at 2,896 participants with type 1 diabetes and 144 participants with type 2 diabetes, using at least 14 days of pre- and post-Control-IQ data.

  • Time in range was improved by 2.1 hours per day in the type 1 group to 77%
  • Time in range was improved by 1.4 hours per day in the type 2 group 79%
  • Both groups spent 96% of time in closed loop.

We learned so much at ADA about improving time in range, and we were moved by the power of automated insulin delivery in doing so, since it shows much greater time in range with what sounds like so less work for people and their healthcare teams.

To learn more about Control-IQ, check out the following articles:

A1C vs. Time in Range – Which Should be Used for Children with Diabetes?

A panel discussion of leading experts, moderated by JDRF CEO Dr. Aaron Kowalski, focused on the pros and cons of using A1C and time in range as primary metrics in diabetes care and management for children. As they debated the best marker of glucose management, they attempted to define the ultimate “goal” of diabetes care: is it preventing complications, spending less time in hyperglycemia and hypoglycemia, or improving mental and emotional wellbeing?

Dr. William Winter presented extensive evidence that A1C can predict a person’s risk of developing complications (kidney disease, heart disease, retinopathy, and neuropathy). While lower time in range has been associated with microvascular complications, experts agree that more studies are needed to determine its predictive accuracy for long-term outcomes. Dr. Thomas Danne presented results from the SWEET project that furthered the case for A1C as a measure of population outcomes: setting ambitious targets based on A1C could lead to significant improvements in outcomes for children with type 1 diabetes.

A1C ethnicity

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Experts discussed cases in which A1C can be misleading and time in range may emerge as a more reliable measure of glucose control. Dr. Winter explained that population A1cs differ among racial and ethnic groups, leading to misdiagnosis (for example, African Americans have a higher A1c on average compared to white people). Very importantly, as diaTribe has reported on for many years in Beyond A1C research, A1C also does not demonstrate hypoglycemia, hyperglycemia, or glucose variability. According to Dr. Danne, healthcare professionals find CGM reports more helpful in identifying daily highs and lows and in adjusting therapy. This technology allows them to better work alongside families to set individual and measurable goals based on time in range – it is terrific to hear about this continued teamwork.

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SENCE

Image source: diaTribe

Though Dr. Danne acknowledged the issue of access and affordability, he believes CGM use will continue to increase among children who are tech savvy. Dr. Daniel DeSalvo presented data from the SENCE and CITY to further support use of CGM among children with type 1 diabetes.

CITY

Image source: diaTribe

Young children (two to seven years old) enrolled in the SENCE study saw their hypoglycemia (blood glucose under 70 mg/dL) and time spent over 300 mg/dL reduce by 40 minutes per day – that’s nearly five hours a week. Teens and young adults (ages 14 to 24) in the CITY study saw a 7% increase in time in range, which is almost two more hours per day spent in range – 100 minutes, to be exact!

The Use of CGM in Type 2 Diabetes — Is There Value?

Continuous glucose monitoring (CGM) has been a revolutionary tool; it gives people real-time updates on their blood glucose levels that can help to increase time in range (TIR). For most providers in diabetes, the value of CGM is now nearly universally supported (either “real-time” or “professional CGM”) even if all people with diabetes can’t get it. Reimbursement throughout much of the world has reinforced the value of CGM in type 1 diabetes almost everywhere, though the value of CGM for people with type 2 diabetes is still being explored.

CGM

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Dr. Philis-Tsimikas argued for CGM for type 2 diabetes given the technology’s ability to offer remote solutions for care management, provide direct feedback of behavior modification, and allow evidence-based changes to drug therapies. Dr. Philis-Tsimikas shared data from several CGM studies in people with type 2 diabetes on a variety of therapies (basal insulin alone, and oral and other medications), highlighting the improvement in clinical and behavioral outcomes. In what could be the most exciting set of results, people with type 2 diabetes who used real-time CGM (RT-CGM) intermittently for 12 weeks showed an average A1C reduction of 1 percentage point at the end of 12 weeks (compared to a 0.5 percentage point reduction in the blood glucose meter control group). During the 40-week follow up period, A1C was still significantly lower in the RT-CGM group.

Dr. Elbert Huang gave what we felt was a less persuasive view. He argued that in most cases, CGM use is not valuable for people with type 2 diabetes, on the basis of cost. Howerver this is based on outdated data – just yesterday at ADA, there was striking Late-Breaker data presented that showed very meaningful reductions in A1c by Dr. Eden Miller and Dr. Gene Wright (he’ll be speaking at the TCOYD/diaTribe Forum Monday night!) The study showed very meaningful A1C reductions in thousands of people with diabetes – starting A1C was 8.5%, which fell to 7.6% to 7.9% depending on the population. Dr. Huang presented two studies that showed that the cost ratio of CGM was different depending on the assumptions of costs related to the quality and quantity of lives impacted by type 2 diabetes. A QALY, by the way, is a “quality adjusted life year” that measures both quantity and quality (based on disease burden) of life years. We also strongly believe that many people become more engaged in their diabetes management due to a variety of factors that reduce stigma (no fingerstick tests required, etc.) and enable them to focus on how data and technology can work together to improve their results.

Dr. Huang suggests that less costly treatments (such as the use of ACE inhibitors to avoid high blood pressure or to prevent kidney disease) might be better areas of focus and certainly all experts would agree that focus here is important as well. He also mentioned potential negative psychological effects of constantly checking blood glucose readings using CGM and the fact that this technology may only work if it is shared with a person’s healthcare team – we agree integration with healthcare teams where available is a valuable point and also emphasize our learnings from ADA 2020 from many providers that emphasize, as Dr. Diana Isaacs did on Saturday, that CGM enables greater interest in diabetes management by people. While the technology is extremely important, Dr. Huang also expressed that it could be more valuable if the price of CGM declines or if it is shown to improve glucose management while also reducing the need for costly medicines, among other factors – these factors of cost are extremely important. CGM is going down in price on average and global pricing of $109/month is already available from FreeStyle Libre all over the world. While no one should have to pay $3/day on their own, we believe many more health systems are interested in investing more here due to the positive results they are seeing. We’ll be back with more data from the ADA 2020 Scientific Sessions on this and related fronts!

Parent Perspectives on DIY Closed-Loop

An observational study on Loop, a do-it-yourself (DIY) automated insulin delivery system (AID), used focus groups to gather the attitudes and experiences of parents and children using Loop. The study followed people using an AID system, continuous glucose monitor (CGM) readings, and a communications bridge device, called “RileyLink.”

Overall, parents felt that Loop had a positive impact on their family’s lives. They reported the following outcomes:

  • Improvements in emotional health as a result of a greater sense of security and normalcy, increased quality of life, and decreased parental stress.
  • Improvements in other areas of life, including management of children’s diabetes at school, quality of sleep, confidence in caregivers, and children’s ability to explore extracurriculars without supervision.

Dr. Anastasia Albanese-O’Neill presented survey results on what parents expect of school and diabetes camp staff to help their children manage their DIY closed-loop system. School nurses were also surveyed on their opinions regarding DIY. Here are some highlights:

  • 29% of parents expect that school staff will assist children with delivering a bolus.
  • Expectations of diabetes camp staff were lower than school staff – 23% of parents expect school staff to assist with carbohydrate counting and timing of bolus, while only 13% of parents expect diabetes camp staff to do those things.
  • Though 46% of school nurses had never heard of DIY before participating in the survey, 33% of them agreed that school staff should help students using DIY who cannot manage it independently.

This suggests a need for training on DIY and diabetes technology for school and camp staff.

Is Technology the Solution to Hypoglycemia? Dr. Bergenstal and Dr. Wilmot Debate

Dr. Richard Bergenstal from the International Diabetes Center (IDC) emphasized the advantages of using continuous glucose monitoring (CGM) for reducing episodes of hypoglycemia (low blood sugar) and other health complications in this debate with Dr. Wilmot. Both doctors are highly regarded, and we took this as a big opportunity to learn lots more rather than land only on one size, though it’s certainly hard to avoid saying yes to this question, from diaTribe’s perspective. Dr. Bergenstal eloquently explained that, on average, hypoglycemia is the biggest barrier to optimal blood glucose management, pointing to the fact that A1C levels increase when people fear going low (what he called the “ripple effect of hypoglycemia”). Luckily, with CGM reports, people can finally detect patterns in hypoglycemia and understand exactly how much time they are spending with blood glucose levels under 70 mg/dL in a day.

Evidence shows that closed-loop technology can reduce and even prevent hypoglycemia. In a study of 124 people with diabetes that Dr. Bergenstal shared, the use of automated-insulin delivery systems (AID) completely eliminated hypoglycemia. This was a historic win – previous studies (see slide below) using low glucose suspend systems (LGS) reduced hypoglycemia by 38%, while predictive low glucose suspend systems (PLGS) reduced hypoglycemia by 59%.

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Image source: diaTribe

Dr. Emma Wilmot argued that while these findings are exciting, technology is only part of the solution. Technology does reduce the risk of hypoglycemia, but is not available to all (particularly those from underserved populations) and is not suited to all. She said that unless CGM is also paired with structured education, it will not provide the significant and lasting improvements in hypoglycemia awareness that the diabetes community needs. We know, of course, how important education is – and diaTribe will be coming back to discuss this in an upcoming piece about a new article just published in Diabetes Care earlier this week (Diabetes Sisters’ CEO Anna Norton was a key author in the new consensus report)!

Early CGM use can help kids and predict T1D progression

The use of CGM across different populations – including people of various ages and different stages of type 1 diabetes – shows that CGM can accurately predict the progression of type 1 diabetes for people at risk. For those transitioning from “stage 2” to “stage 3”, continuous monitoring can also help prevent DKA, which many people with type 1 have at diagnosis. While there are no clinical guidelines at the moment for how to manage “stage 2” type 1 diabetes, the TESS study is currently evaluating the benefits of CGM use in this population. “Staging” of type 1 diabetes is fairly new and we will be thinking about this more as we consider how to further improve education about type 1 diabetes.

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Experts all agreed that earlier use of CGM could result in better diabetes management later on. Dr. Jan Fairchild studied the start and continued use of CGM in a pediatric population with early “stage 3” type 1 diabetes. Kids who started CGM at diagnosis had slightly higher CGM wear at 24 months, compared to kids who started within the first two years of diagnosis (78% vs. 66%, respectively), though this result was not significant. All children using CGM ultimately benefitted – they demonstrated a median A1C of 7.7% at 24 months, which was less than the clinic median A1C of 8.1%. Dr. Fairchild also mentioned the educational role that early CGM use could play, especially with a focus on time in range.

Diabetes Drugs

VERTIS-CV Trial of Steglatro and Heart and Kidney Health

Dr. Samuel Dagogo-Jack and Dr. Christopher Cannon presented highly anticipated results from the VERTIS-CV trial, which studied the effects of Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin) on over 8,000 participants with type 2 diabetes and cardiovascular disease (CVD). The trial found that treatment with Steglatro reduced average A1C by 0.5 percentage points, lowered average weight by nearly five pounds, and reduced blood pressure compared to standard diabetes treatment. Steglatro also improved kidney function, as measured by eGFR, and reduced the number of study participants with heart failure.

The researchers agreed that the VERTIS-CV results confirm the current guidance on the use of SGLT-2 inhibitors to prevent and treat heart failure and diabetes-related kidney disease. As a reminder, the current ADA Standards of Care advise using SGLT-2 inhibitors in people with type 2 diabetes for reducing hyperglycemia (high blood sugar), improving blood pressure, and facilitating weight loss. SGLT-2 inhibitors have also been shown to improve heart and kidney health in people with and without diabetes.

Read more about the trial in our full article here.

New Data Shows Teplizumab Delays Diagnosis of Type 1 Diabetes

At last year’s ADA, we were very excited to report on trial results that showed teplizumab (pronounced Tep-pli-ZU-mab!) delayed type 1 diabetes diagnosis by two years, compared to placebo. The study enrolled 76 participants (55 children and 21 adults) who were the relatives of people with type 1 diabetes and did not have diabetes, and were at high risk for developing the condition (they had unstable blood glucose levels and at least two diabetes-related antibodies). On average, time to diagnosis of type 1 diabetes for the teplizumab group was four years, compared to two years with placebo. At the end of the trial, 53% of the teplizumab-treated group did not have type 1 diabetes, compared to 28% of the placebo group.

New follow up data, presented by Dr. Emily Sims (Indiana University), showed sustained reduction in the onset of type 1 diabetes. Previously, teplizumab had been proven to delay clinical onset by only two years in high-risk people; however, these new data support a delay of as much as three years, compared to placebo.

Furthermore, people who were treated with teplizumab showed a “striking reversal” in C-peptide decline (this is a common measure of type 1 diabetes) in the six months following treatment, after which C-peptide levels seemed to stabilize. These data suggest that the treatment helped stabilize beta cell function (the cells in the pancreas that make insulin) and that repeated teplizumab treatment at key time points may be able to further extend, delay, or even prevent diagnosis of type 1 diabetes. While not a cure, three years of living without daily diabetes management is certainly a meaningful outcome.

When will teplizumab become available? With an estimated six-month review time if Priority Review is granted, an FDA decision could be expected as soon as mid-2021.

SGLT-2 Inhibitors and GLP-1 Agonists to Prevent Heart Disease

Dr. Mikhail Kosiborod (University of Missouri-Kansas City) and Dr. Darren McGuire (University of Texas Southwestern Medical Center) debated the use of SGLT-2 inhibitors and GLP-1 agonists in primary prevention of heart disease (called cardiovascular disease, or CVD).

As background, primary prevention is using medication in people who do not have CVD in order to prevent CVD. This is different from secondary prevention in which a person who is diagnosed with CVD uses a medication to prevent progression of the disease.

Dr. Kosiborod started the session with a strong “yes” – SGLT-2 inhibitors and GLP-1 agonists should be used for primary prevention. However, primary prevention is difficult to prove: larger and longer trials are needed. Dr. Kosiborod believes that we do have enough evidence.

  • A meta-analysis of SGLT-2 inhibitor trials suggests that:
    • SGLT-2 therapy works to prevent heart failure regardless of whether a person has established CVD (based on hospitalizations for heart failure).
    • SGLT-2 therapy protects kidney health regardless of whether a person has established CVD.
  • The FDA has approved SGLT-2 inhibitor Farxiga for people with type 2 diabetes and established CVD, and those with risk factors for CVD. That is primary prevention!
  • REWIND showed that GLP-1 agonist Trulicity prevents major adverse cardiovascular events (MACE, which includes stroke, heart attack, and cardiovascular death) in people with and without established CVD.
  • The FDA agrees again here – Trulicity is approved for people with type 2 diabetes with CVD and those with risk factors for CVD.
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Next, Dr. Kosiborod looked at the population level. Worldwide, primary prevention with SGLT-2s and GLP-1s will significantly reduce cardiovascular events (compared to secondary prevention alone) because there are many people who are not diagnosed with CVD.

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Dr. Kosiborod believes this primary prevention is cost-effective and essential, given the high risk to the population. And many SGLT-2s and GLP-1s will become generic in the future.

Dr. McGuire argued that we are not ready for SGLT-2s and GLP-1s to be used in primary prevention. He pointed to a meta-analysis that showed no benefit of SGLT-2 inhibitors and GLP-1 agonists in atherosclerotic cardiovascular disease (ASCVD) outcomes compared to placebo in people without established ASCVD. In his analysis of REWIND, Dr. McGuire pointed to an absolute risk difference of 0.3% in people without established CVD taking Trulicity versus placebo (1.7 events for every 100 patient years, vs. 2.0 events for every 100 patient years). This would mean that you would need to treat 333 people without CVD to prevent one MACE – which would be $3.4 million in drug costs.

Both speakers agreed that SGLT-2 inhibitors have shown strong effects in primary prevention for heart failure and kidney outcomes. There was no significant debate on this point, as the data speak for themselves regarding the profound effect of SGLT-2 treatment in reducing these outcomes.

Weekly Basal Insulin – The Wave of the Future?

New types of insulin – once-weekly basal insulin injections – are being tested in clinical trials and may bring major developments to how people take insulin. In this session, Professor Philip Home, Dr. J. Hans DeVries, and Dr. Stefano Del Prato discussed the pros and cons and recent results from clinical trials of weekly basal insulin.

Prof. Home explained that weekly insulin could reduce hurdles in starting or maintaining insulin therapy for people with diabetes, especially those who are:

  • Afraid of injections
  • Hesitant to start insulin due to the change in lifestyle or impact on quality of life
  • Wary about handling devices
  • Already on a weekly injectable GLP-1 agonist

Weekly insulin could help people adhere to their prescribed therapy – but it will likely make dose titration and adjustments more challenging. One of the major challenges of weekly insulin is that people can’t modify insulin doses according to life disruptions (for example, sick days or increased physical activity).

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Dr. DeVries and Dr. Del Prato reviewed the various weekly insulins that companies are studying to evaluate their safety and how they affect diabetes outcomes in comparison to existing insulins. Dr. Del Prato highlighted results from a recent study that compared Novo Nordisk’s weekly insulin (icodec) to Glargine U100 (Lantus) in people with type 2 diabetes:

  • Both insulins showed a similar reduction in A1c.
  • Icodec showed improved glucose profiles for self-monitored blood glucose (SMBG).
  • Rates of hypoglycemia were low for both insulins.
  • Weight gain, which is common when starting insulin, was the same for both insulins.
  • Icodec did not show any new safety issues.

Research is still to come on weekly basal insulin, but it looks promising.

Farxiga for Diabetes Prevention? New Analysis of DAPA-HF Trial

Yale’s Dr. Silvio Inzucchi presented an analysis of the landmark DAPA-HF trial, suggesting that along with the heart health benefits of SGLT-2 inhibitor Farxiga, an additional benefit of preventing type 2 diabetes also exists.

As background, DAPA-HF examined the heart health effects of Farxiga (spelled Forxiga in Europe) in people with and without type 2 diabetes. The trial showed that:

  • Farxiga reduced heart-related death or worsening heart failure by 26% compared to placebo (a “nothing” pill).
  • The heart benefits were the same in people with diabetes and without diabetes.

Dr. Inzucchi’s new analysis showed that for participants who did not have type 2 diabetes at the start of the trial, treatment with Farxiga reduced the risk of developing type 2 diabetes by a whopping 32% compared to placebo. After 18 months, 4.9% of the Farxiga group had been diagnosed with diabetes compared to 7.1% of the placebo group. This is a big deal and anyone you know at high risk of type 2 diabetes should learn about these results and talk to their doctor or healthcare team.

We’re glad to see this important benefit – type 2 diabetes prevention – may be conveyed to people with heart failure who can now take Farxiga regardless of whether or not they have type 2 diabetes. As a reminder, Farxiga is the first SGLT-2 inhibitor drug to be approved for a non-diabetes specific population.

Metformin, GLP-1 agonists, and SGLT-2 inhibitors in Type 1 Diabetes

UCSD’s Dr. Jeremy Pettus moderated a session with three expert presenters from across the world: Dr. Irene Hramiak (Western University), Dr. Tina Vilsboll (Steno Diabetes Center Copenhagen), and Dr. Chantal Mathieu (University Hospital Gasthuisberg Leuven).

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Dr. Hramiak kicked things off discussing the current challenges and risks of insulin therapy, including hypoglycemia, weight gain, glucose variability, and diabetic ketoacidosis (DKA). According to data from the T1D Exchange, average A1C levels have not improved in the last decade, and adolescents continue to be a difficult group for glycemic management, despite increased use of pumps and continuous glucose monitors (CGM). How can adjunctive therapies (added to insulin) help?

The REMOVAL study looked at the effects of metformin in people with type 1 diabetes (40 years of age or older). Over three years, participants taking metformin saw the following benefits compared to those taking a placebo:

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  • A decrease in A1C of 0.13 percentage points
  • A reduction in insulin dose by 1.2 units
  • No change in the rate of minor or severe hypoglycemia
  • From a baseline body weight of 193 lbs (87.7 kg), a weight loss of 2.6 lbs (1.17 kg)
  • A reduction in LDL (“bad”) cholesterol by 0.13 mmol/L (5 mg/dL)

These data suggest that metformin did not have a clinically meaningful impact on glycemic management but may improve cardiovascular health in adults with type 1 diabetes. That’s disappointing, but something we’ve all wondered for years – now we know!

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Dr. Vilsboll continued the conversation by discussing GLP-1 agonists for type 1 diabetes. She reminded that adjunctive therapy has several important goals but does not replace insulin – which is the main treatment for people with type 1 diabetes.

Dr. Vilsboll provided an overview of the effect of GLP-1 drugs in the pancreas (on insulin-producing beta cells), liver, brain, kidneys, and other organs before sharing data from a trial on GLP-1agonists in type 1 diabetes.

The LIRA-1 Study evaluated 24 weeks of GLP-1 agonist use in people with type 1 diabetes and excess weight and found that GLP-1 treatment:

  • Did not have a statistically significant (meaningful) reduction in A1C compared to placebo.
  • Reduced body weight by 13.4 lbs (6.1 kg) compared to placebo (from a baseline of about 205 lbs, or 93 kg).
  • Increased gastrointestinal side effects (nausea, diarrhea).
  • Did not decrease the amount of bolus insulin required but reduced basal insulin by about five to six units per day.

The ADJUNCT trial was the longest such trial, involving 1,400 people with type 1 diabetes with an A1C between 7%-10%. In this trial, participants taking GLP-1 agonists experienced:

  • A clinically significant reduction in A1C of 0.54 percentage points compared to a baseline of 8.2% after 52 weeks.
  • A reduction in body weight that correlated with the dose of GLP-1 agonist: 10.8 lbs (4.9 kg) of weight loss with a 1.8 mg dose of GLP-1 agonist; 7.9 lbs (3.6 kg) with a 1.2 mg dose; and 4.9 lbs (2.2 kg) with a 0.6 mg dose.
  • An increased rate of symptomatic hypoglycemia, but no increase in severe hypoglycemia or DKA.
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In a more recent trial, MAG1C, researchers examined the use of GLP-1 agonist exenatide (Byetta) over 26 weeks in adults with type 1 diabetes. Researchers found that compared to placebo, the GLP-1 agonist did not decrease A1C but did decrease insulin dose and body weight. Researchers concluded that the GLP-1 agonist does not have a future as an add-on treatment to insulin in type 1 diabetes. We are not certain this is the correct answer, because it seems like TIR would’ve been useful to measure – but, there’s no fighting city hall.

The session concluded with Dr. Chantal Mathieu discussing the role of SLGT-2 inhibitors in people with type 1 diabetes. She pointed to three main trials: DEPICT with Farxiga, InTANDEM with Zynquista, and EASE with Jardiance.

Compared to placebo, participants taking Farxiga (either 5mg or 10mg dose) experienced:

  • Approximately a 0.45 percentage point drop in A1C by 24 weeks, and 0.2 to 0.3 percentage point decrease in A1C after 52 weeks.​
  • time in range increase of about 10% – a gain of almost two more hours of time in range per day

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  • A 10% decrease in both basal and bolus insulin.
  • A decrease in body weight of about 5.5 lbs (2.5 kg) with a 5mg dose, and about 7.7 lbs (3.5 kg) with a 10mg dose (from a baseline of 179 lbs, or 81 kg).
  • An increased risk of genital infection and urinary tract infections.
  • No increase in hypoglycemia.
  • An increased risk of DKA that rises with a larger dose.

The inTandem trial also showed a drop in A1C: after 24 weeks, participants taking Zynquista experienced a 0.5 percentage point drop in A1C compared to those taking placebo. Time in range also increased with Zynquista. There was a 77-minute increase in time in range with the 200 mg dose, and almost a three-hour increase for people taking the 400mg dose. The increased risks of DKA and genital infections were also observed in this trial.

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The EASE trial provided evidence that supported the effects of SGLT-2 inhibitors on the reduction of A1C – about 0.3-0.4 percentage points after 52 weeks. This study also used a much lower dose of 2.5 mg, which offered an intermediate effect – lowering A1C by about 0.2 percentage points and reducing body weight by 4 lbs (1.8 kg). Interestingly, there was no difference in DKA with the 2.5 mg dose compared to placebo.

Dr. Mathieu concluded by sharing her “bottom line” on the use of SGLT-2 inhibitors in type 1 diabetes and preventing DKA.

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To learn more about off-label drugs in type 1 diabetes, check out this article from Kerri Sparling.

What Therapies Are Best for People with Type 2 Diabetes at Risk of Heart Disease?

The world of diabetes is now focusing more than ever on preventing diabetes-related health complications. Not only is the treatment of diabetes about blood sugar (measured by A1C or time in range), but it is also about heart health, kidney health, and so much more. In 2019, data from large trials showed that GLP-1 agonists and SGLT-2 inhibitors have heart and kidney protection benefits.

As such, experts strongly emphasized using GLP-1 or SGLT-2 drugs for individuals at high-risk for heart attack, stroke, heart failure, or chronic kidney disease. They also named that GLP-1 and SGLT-2 therapies should become more accessible and affordable to people living with diabetes.

Studies have not yet evaluated the heart and kidney health benefits of metformin, compared to those of GLP-1s and SGLT-2s. However, trials have shown that metformin helps lower blood glucose and body weight, comes with a low risk of hypoglycemia, and is cost-effective.

If your healthcare professional has not brought up additional therapy options for you, we recommend you ask them to read this article and discuss your options.

A Debate on the Use of Sulfonylureas in Type 2 Diabetes

Sulfonylureas, or SUs (drugs like glimepiride, glipizide, gliclazide), are a commonly prescribed low-cost drug for people with type 2 diabetes across the world. At ADA 2020, experts Dr. Sophia Zoungas and Dr. Carol Wysham debated the role of SUs in the treatment of type 2 diabetes. While the two endocrinologists differed on how to interpret data from various studies, we came away from the debate with several important take-aways.

Benefits of SUs:

  • Like many other compounds available today, SUs can help lower A1C, especially at the beginning of use in diabetes management.
  • SUs are low-cost and can be an economical method of managing diabetes, at least in the short term.
  • The CAROLINA study demonstrated that sulfonylurea glimepiride is safe for the heart in people with type 2 diabetes.

Challenges of SUs:

  • The CAROLINA study showed that SUs lead to a greater risk of hypoglycemia than other type 2 diabetes medications (not including insulin).
  • All SUs are associated with weight gain, which itself is associated with cardiovascular disease for many people with diabetes.
  • Not all SUs are created equally – each SU might have different health risks, so more research needs to be done on this front.
  • Preventing long-term complications is possible with GLP-1 agonists and SGLT-2 inhibitors – SUs confers no cardioprotective advantages.
  • Without the cost advantage in the short-term, no one would use SUs.
  • Clinical trial investigators are sometimes discouraged from using SUs in major trials, as we understand it.

If you do use an SU, and have experienced hypoglycemia or weight gain, we encourage you to ask your healthcare professional if there is an alternative. To increase safety, we encourage you to check blood sugar as often as you can (or start using a continuous glucose monitoring device, if you can get access – see here if you are on Medicare) to minimize the risk of hypoglycemia.

The Debate on Metformin and Insulin Use During Pregnancy Continues

Traditionally, healthcare professionals have been advised to use insulin to treat pregnant women who have type 2 diabetes or gestational diabetes (GDM). Now, there is debate about whether metformin or other medications are equally effective alternatives to insulin.

Dr. Denice Feig presented data showing that in pregnant women with GDM, metformin use resulted in less maternal weight gain, less preeclampsia (pregnancy-related high blood pressure), lower birth weight, and less neonatal hypoglycemia (low blood sugar). Additionally, there is no evidence that metformin causes any abnormalities in babies, and the drug may reduce insulin resistance in the fetus. During the first trimester of pregnancy, metformin may be a reasonable alternative, if not a first-line treatment equivalent, to insulin. It is also cheaper, easier to use, and poses less of a risk for hypoglycemia (low blood sugar) than insulin.

While the data are promising, both Dr. Feig and Dr. Linda Barbour pointed out that long-term effects on the baby due to exposure to metformin during pregnancy may include a greater risk of being overweight, developing obesity, and having a higher BMI. Unfortunately, the data did not include pregnant women with type 2 diabetes; an ongoing study, MiTy, is currently studying these effects. Both Dr. Feig and Dr. Barbour emphasized that we need more data to decide the best treatment for pregnant women with diabetes – that may well be, and we also hope that better screening is in the works, so that those at risk of gestational diabetes can learn about it earlier and work with their healthcare teams to live with it successfully, which is eminently possible. Learn more about gestational diabetes in our recent article by Cheryl Alkon.

Nutrition, Exercise, and Mindset

New Physical Activity Recommendations for Adults and Children

Dr. Katrina Piercy and Dr. Ronald Sigal presented the 2018 Physical Activity Guidelines for Americans, with updates to the age-specific guidelines and evidence of even more health benefits. These are the recommendations for each age group:

  • Children ages 3-5 should be physically active throughout the day to support their growth, development, and motor skills. Though the US guidelines do not include a specific amount of time, Australia, the United Kingdom, and Canada recommend three hours per day.
  • Children ages 6-17 should do at least 60 minutes a day of moderate or vigorous physical activity.
  • Adults (under age 55) should do at least 150 minutes (2.5 hours) to 300 minutes (5 hours) each week of moderate-intensity activity, or 75 minutes (1 hour and 15 minutes) to 150 minutes (2.5 hours) each week of vigorous-intensity aerobic physical activity. Adults should also do muscle-strengthening activities at least twice a week. We were slightly surprised not to see adults urged to exercise every day like former head of CMS/FDA Dr. David Kessler does in his recent acclaimed book, Fast Carbs, Slow Carbs.
  • Older adults (above age 55) should do the recommended aerobic and muscle-strengthening activities for adults. They should also incorporate balance and functional training, such as standing on one foot or ballroom dancing.

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How do you determine the intensity of exercise? Dr. Piercy recommends the “talk test”: someone doing moderate-intensity aerobic activity can talk, but not sing, during the activity, while a person doing vigorous-intensity activity cannot say more than a few words without pausing for breath.

The speakers noted that while the most health benefits come with at least 150-300 minutes of moderate physical activity per week, any activity is beneficial: any time spent sitting that is swapped out for exercise (even light activity,) can lead to short-term and long-term health benefits. Read more about the guidelines here.

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Diabetes Self-Management Education and Support (DSMES) 2020 Consensus Report Recommendations

A group of educators made a strong case for the greater use of diabetes self-management education and support (DSMES). The benefits are many, including improvements in clinical, behavioral, and psychosocial outcomes, and greater diabetes knowledge and self-care behaviors. Dr. Margaret Powers stressed that compared to other treatments prescribed by healthcare professionals, DSMES and medical nutrition therapy produce few to no negative side effects for people with diabetes and are low cost.

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The experts discussed low DSMES participation rates across the nation and the factors that reduce referrals to diabetes education. Evidence shows that less than 5% of people newly diagnosed with diabetes who have Medicare insurance, and 6.8% of privately insured people with diabetes, have used DSMES services. The 2020 DSMES Consensus Report was created to address these concerns by outlining steps healthcare professionals can take to help people access DSMES services. The report recommends that healthcare professionals make referrals and encourage participation in DSMES at four critical times in someone’s diabetes journey: (1) diagnosis, (2) annually or when not meeting treatment targets, (3) when complicating factors develop, and (4) when transitions in life and care occur. It also suggests that awareness of, and access to, DSMES must be expanded (culturally and geographically), and financial support should be provided for use of DSMES services.

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Food as Medicine! Geisinger’s Fresh Food Farmacy

Michelle Passaretti (Geisinger Health System) presented data on the success of the Fresh Food Farmacy initiative. Fresh Food Farmacy was developed to meet the health needs of people with diabetes in Pennsylvania who do not have access to healthy foods (also known as being food insecure). diaTribe interviewed two leaders from Geisinger in 2018, Dr. Andrea Feinberg and Allison Hess; now, Fresh Food Farmacy has provided 482,219 total meals.

The data speaks to the power of food as medicine! The program participants had a:

  • 2 percentage point reduction in A1C from a baseline of 9%
  • 27% reduction in fasting glucose
  • 13% reduction in cholesterol (including a 9.9% reduction in “bad” LDL cholesterol)
  • 15% reduction in triglycerides

Fresh Food Farmacy also led to increased use of preventive care: flu shots increased by 23%, annual eye exams increased by 17%, and annual foot exams increased by 33%.

Compared to eligible individuals who did not participate, Fresh Food Farmacy participants saw:

  • 49% lower hospital admissions rates
  • 13% decrease in emergency department visits
  • 27% more primary care visits
  • 14% more endocrinologist visits

Participant surveys show significant improvements in quality of life, with 31% of people in the program rating their overall health as very good, compared to just 6% before participation. Additionally, 44% of Fresh Food Farmacy participants now rate their emotional and mental health as very good, compared to just 9% before the program. Passaretti emphasized that Fresh Food Farmacy is not a diet, but a lifestyle change, and that support for the individual’s entire household is necessary for success.

A Sneak Peek into the Film Blood Sugar Rising

Blood Sugar Rising is a film that powerfully articulates the need for a war on diabetes. During this panel moderated by our own Kelly Close, we heard from ADA CEO Tracey Brown, Rise and Root urban farmer Karen Washington, social media influencer and film star Nicole Egerer, film director David Alvarado, and incoming ADA Chief Scientific & Medical Officer Dr. Robert Gabbay.

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Many myths exist in diabetes. One is that if you get diabetes, it is your fault. Blood Sugar Rising dismantles some of these false narratives by showing the complexity of the disease and amplifying diverse voices of people in the diabetes community. Watch the film here if you are in the US and here if you are outside the US.

Tracey Brown ended with a powerful call to action: “What will we do when the burning bush stops burning? We need to move from words into action. We get one point for saying and nine points for doing. Each of us can use our voice, our monetary power, and our ears, and reach across the aisle to collaborate. This is what we need to do to bring diabetes down. We can make it happen, but only together. I’m full up of hope and courage that tomorrow is going to be better than today.”

Lifestyle Interventions for Type 2 Diabetes Remission

In a fascinating session on type 2 diabetes remission, several leaders in the field introduced data on how specific lifestyle interventions (diet and exercise) may help put type 2 diabetes into remission.

Alison Barnes presented data from the DiRECT trial, which focused on low-calorie diets (LCD). The trial compared an intervention group on an LCD (between 800-900 calories per day) to a control group receiving typical diabetes care. Remission was defined as achieving an A1C below 6.5% and stopping all diabetes medications. Results from the DiRECT trial were promising:

  • At one year: 4% remission in control group and 46% remission in the intervention group.
  • At two years: 3% remission in control group and 36% remission in the intervention group.
  • 64% of participants who lost more than 22 lbs (10 kg) were in remission at two years.
  • The intervention group dropped from 75% of participants on diabetes medications at baseline to 40% at two years (compared to 77% at baseline and up to 84% in the control group).
  • Average A1C decreased by 0.6 percentage points in the intervention group at 2 years.
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We thoroughly recommend Dr. Roy Taylor’s book Life Without Diabetes: The Definitive Guide to Understanding and Reversing Type 2 Diabetes – he provides a major connection to the DiRECT trial.

Next Dr. William Yancy spoke on low-carbohydrate diets (classified as less than 130 g carbs per day, with no overall calorie restrictions). In an analysis that compared the effects of nine different diets on glycemic outcomes in type 2 diabetes, the low-carb diet was ranked as the most effective dietary approach for lowering A1C.

Finally, Dr. Kristian Karstoft presented the U-TURN study on how exercise alone, or exercise and diet, may play a role in type 2 diabetes remission. U-TURN had two groups, one receiving standard care and one receiving intensive lifestyle intervention, which included diet and exercise components.

  • After 12 months, 37% of participants in the intervention group stopped using glucose-lowering medication and maintained glucose levels below the criteria for type 2 diabetes (effectively achieving remission).
  • Of the participants who achieved remission, the majority of them came from the group that consistently exercised the most.

The Need for a Personalized Approach to Obesity Treatment

Experts shared the latest data on different treatments for obesity. They focused on three approaches:

1. Lifestyle interventions:

  • The Look AHEAD trial tested whether reducing calories and exercising regularly would lead to diabetes remission. After one year, 11.5% of participants achieved diabetes remission with an average weight loss of 19 pounds (8.6 kilos). After four years, 7.3% of participants were able to maintain remission with an average weight loss of 10 pounds (4.5 kilograms).
  • The Diabetes Remission Clinical Trial (DiRECT) tested whether calorie restriction alone had an effect on diabetes remission. After one year, 46% of people in this study with type 2 diabetes achieved remission; after two years, 70% of the people who had achieved remission were able to maintain remission.

Participants in Look AHEAD had more advanced diabetes than in DiRECT, leading to the big difference in remission rates. The speakers emphasized that the longer someone has been diagnosed with diabetes, the harder it is to achieve diabetes remission.

2. Obesity medication:

  • Just 2% of people living with obesity are managing the disease with medication. However, many obesity medications can lead to weight loss, prevention of diabetes, and diabetes remission.
  • Combination therapy has shown success for managing obesity and type 2 diabetes. A study testing tirzepatide (a dual GLP-1 and GIP receptor agonist) in people with type 2 diabetes found a 1.7-2% decrease in A1C and an average weight loss of 12 pounds in just 12 weeks.

3. Bariatric surgery:

  • Experts agreed that bariatric surgery should be considered as a treatment option for people with a BMI greater than 35. Bariatric surgery can also lead to sustained weight loss and a decrease in diseases associated with obesity, including sleep apnea and heart disease.
  • It’s clear that obesity treatments must be determined at individual levels – we know that so much more is possible for people with diabetes to reach healthier weights and will be returning to this topic. In the meantime, if changing your weight is of interest, talk to your doctor about how to do this in the best way for you.

How Might Type 1 Diabetes Affect the Gut Microbiome? How Can We Use the Gut Microbiome to Treat Type 1 Diabetes?

Though the science is not yet conclusive, research continues on the relationship between the gut microbiome (made up of all the bacteria that live in the human digestive tract) and type 1 diabetes autoimmunity. Dr. Eric Triplett reviewed studies of the gut microbiome in babies with high genetic risk for type 1 diabetes. Three of the studies (DIPP, Babydiet, and DIABIMMUNE) showed an association between the species of bacteria living in the gut and the onset of type 1 diabetes. He then presented a study using data from the general population in Sweden (ABIS), which compared the gut microbiome of children with low, neutral, or high genetic risk for type 1 diabetes. The study found that high genetic risk for type 1 diabetes is associated with changes in the gut microbiome early in life.

Dr. Emma Hamilton-Williams shared unpublished research on the effect of high-fiber dietary supplements on gut microbiome composition and diabetes management in 18 adults with type 1 diabetes. Fibrous food breaks down into short-chain fatty acids (SCFAs) when digested. SCFAs are known to support gut health and regulate the immune system. The study found that the high-fiber supplements affected the species of bacteria living in the gut as well as their function (though these returned to baseline after the diet ended). Participants with better-managed diabetes at baseline had a stronger response to the dietary change – and experienced changes in their glycemic management: A1C levels decreased and less daily insulin was required. Further research on short-chain fatty acid supplements could shed lead on diabetes treatment and prevention.

Real World Stories: Supporting People at Different Stages of Diabetes

Dr. Neesha Ramchandani presented her work on young adults living with diabetes (ages 18 to 30). Through interviews, she found four main challenges: finding a balance between diabetes and life, feeling in control of diabetes, navigating the hidden burden of diabetes within their social circles, and wanting a better connection with their diabetes healthcare professional. One participant said, “Diabetes is like having a full-time job… you can’t 100% turn off. It always has to be a part of your thought process.” diaTribe has resources for teens here.

We then heard from Dr. Della Connor and Dr. Gary Rothenberg on the need to care for people who are living with diabetes post-kidney transplants and post-amputations. In all three talks, the experts emphasized the need to:

  • Build trust and comfort between people with diabetes and healthcare professionals.
  • Incorporate perspectives based on gender, race, and ethnicity into care.
  • Recognize the importance of a team approach, including care-partners.

Access to Care and Policy 

Soda Taxes: Are They Working?

Dr. Lisa Powell (University of Illinois at Chicago) presented compelling evidence in support of sugar-sweetened beverage (SSB) taxes and their ability to reduce soda consumption. Evidence suggests that taxes do reduce the consumption of sugary beverages – a 38 percent reduction in Philadelphia, PA and 21 percent reduction in Seattle, WA, for example – and incentivize soda companies to decrease the amount of sugar in their products, especially when the tax is dependent on the drink’s sugar content. Research also shows that while some consumers replace sodas and sugary drinks with other forms of sugar, such as candy or chocolate milk, the most common substitute is water.

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Dr. Martin White (University of Cambridge) and Dr. Rafael Meza (University of Michigan) presented promising data on how SSB taxes are working in the United Kingdom and Mexico, respectively. UK consumers overall have been switching to drinks with less sugar and most companies have been reducing levels of sugar in their products; however, taxes have not had a dramatic negative impact on the sugary beverages industry’s revenues overall. Similarly, Dr. Meza showed that Mexico’s overall sugar consumption has decreased since the implementation of the SSB tax, having the largest influence on people who drink lots of sugary drinks, and he noted that the current tax, which is about 10% of the beverage price, would have a significantly larger impact if doubled.

Dr. Powell pointed out that the most effective taxes require careful design. To significantly curb consumption of sodas, the SSB tax should be added into the shelf price, rather than applied at the register, and the tax ought to apply to a broad base of sugary-drinks (including sodas, juices, sports drinks, etc.) to avoid substitutions. Moreover, researchers must be mindful of cross-border shopping – this is when consumers purchase their beverages in places where the SSB tax doesn’t apply. This tax avoidance can heavily impact the effectiveness of the tax: for example, in Philadelphia, PA, consumers buying SSBs outside of Philly reduced the the impact of the tax from a 51% reduction in SSB sales to a 38% reduction.

Effects of Health Policy on Diabetes Care

Professor Rebecca Myerson (from the University of Wisconsin) shared key findings of a study on the impact of Medicaid expansion for people with diabetes:

  • Medicaid prescriptions for insulin increased by about 40%, even with rising insulin prices, meaning that more people with diabetes are receiving treatment.
  • Prescriptions for metformin also increased, suggesting that more people are getting treatment for early-stage diabetes.
  • About one-third of the other prescriptions are for newer medicines (such as SGLT-2 inhibitors and GLP-1 agonists) – promising trends for preventing diabetes complications and saving significant costs down the road.

Dr. Kasia Lipska from Yale School of Medicine discussed the importance of coverage for essential medicines and pre-existing conditions – two health policy issues that are front of mind for many Americans as the November election approaches. In addition to Medicaid expansion, the Affordable Care Act (ACA, or Obamacare) provided coverage for “Essential Health Benefits,” which includes prescription drugs, mental health services, emergency services and hospital care, preventive services and chronic disease management, and more. Dr. Lipska shared a study that found the ACA reduced the percent of income spent on family medical costs for people ages 18-64 with diabetes. This reduction was especially true for people whose family income was in the lowest bracket ($0-34,999 per year).

Income

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Importantly, ACA also prohibited health insurance companies from denying people coverage or charging higher costs to people who have “pre-existing conditions,” including diabetes. Given the significant improvements in coverage and care, Dr. Lipska emphasized that getting rid of the pre-existing conditions provisions would be “a disaster for people with diabetes” – presumably diaTribe readers in the US would agree! Over half of those surveyed were in favor of expanding Medicaid programs in their state – this doesn’t surprise us, since there are so many states that do not have favorable diabetes care programs (for example, see our article on CGM coverage for people on Medicaid; although this was not part of the ACA, many cite it as helping improve care quickly for those that are able to access the benefit). She shared results of a Kaiser Family Foundation survey that emphasized the need for ACA provisions:

ACA

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Whole-Population Interventions Aim to Prevent Type 2 Diabetes

As type 2 diabetes rises in the United States (and around the world), organizations are working to prevent new cases and improve the health and wellness of entire communities. Simon Neuwahl (RTI International) showed models of the benefits of proposed changes, which includied soda taxes, worksite health promotion, and bike lanes. The models suggest that the introduction of these three societal reforms can reduce the rate of type 2 diabetes by 17% over the next ten years. In 2018, 1.4 million people were diagnosed with type 2 diabetes in the, US so a 17% decrease would prevent 2.4 million cases over ten years.

There is still a long way to go. The CDC is aiming for the rate of type 2 diabetes to drop by 21% by 2025. The efficacy of some reforms, like the soda tax, are well proven. But, experts like Professor Nicholas Wareham (University of Cambridge, England) believe that no single intervention can make a difference. Decreasing rates of type 2 diabetes will require societal and individual lifestyle reforms.

Thankfully, diverse groups recognize the need for holistic approaches to diabetes prevention. The CDC’s National Diabetes Prevention Program coordinates with both public and private organizations to connect people with diabetes or prediabetes to lifestyle change resources and programs. Neuwahl’s cost-effective model is adaptable to national, state, and local communities hoping to implement whole-population interventions. Together, his three proposed population-level reforms could directly improve the lives of 2.4 million people.

Source: diabetesdaily.com

Using Smartphone Tracking to Identify Patients with Depression (ADA 2020)

At the American Diabetes Association (ADA) 80th scientific sessions last week, Dr. Ashutosh Subharwal, Department Chair and Director of Department of Electrical and Computer Engineering at Rice University, put together a compelling presentation that showed the benefits of using smartphone sensors to measure behavior-biology pathways and use those findings to assess, treat and improve healthcare outcomes for depressed patients living with diabetes.

Scaleable Health Labs believes that there should be a bio-behavioral sensing layer to healthcare using simultaneous, non-invasive and accurate measures to provide clinicians with data to better help their patients. They feel using quantitative data from a sensor-based automatic measurement will be more useful than asking patients questions and having their answers be based on their own perception. For example, when asking patients how often they exercise, their answer may vary drastically from the data from their sensor.

The presentation focused on 3 areas: Mobile bio-imaging, behavioral sensing, and data science for health.

Dr. Subharwal proposed two questions:

  1. Can we track depressive/anxiety states?
  2. Can we measure loneliness?

Can We Track Depressive/Anxiety States?

Depression is a common comorbidity of diabetes and is often undetected and untreated. A study explored this in adults and adolescents, using a tool called SOLVD: Smartphone and Online Usage as based eValuation for Depression, by way of a smartphone as a wearable for tracking depression.

The two clinical pilots for SOLVD consisted of the following:

  • Bi-weekly clinical visits.
  • Logging feelings in a MoodReminder Module.
  • The MobileLogger Module, which has the sensor logging social use (phone calls/texts), mobility (GPS/steps/accelerometer) and phone usage (screen time, screen light, etc.), all while being respectful to keep any conversations private.
  • A new parent app for the teenage pilot that used the parent’s feedback as a sensor to measure their children’s mental well-being.

Using this combinational sensor data allowed clinicians to track who, when and for how long the patient was speaking with or texting an individual. They were able to track where the patient was going and the duration of time spent at each location. There were also many other extracted features from the smartphones related to communications, mobility and sleep collected daily, as listed in the chart below.

Key Findings

This method proved to be a useful way to continuously track a patient’s mental state. The patients did not find it intrusive and were willing to be tracked. They saw a strong correlation between the daily self-reported moods and different diagnostic questionnaires in both teens and adults. Also, when patients had fewer phone calls/text messages and shorter frequency of these exchanges, it was predictive of higher depression symptoms. Additionally, as the number of steps walked decreased, there was an increase in the participant’s depressive state.

In both studies, there was a correlation between the data collected from the smartphone and the patient’s psychometric scores, and a noticeably stronger correlation in the moderate to severely depressed participants. The data indicate that the more depressed a patient was, the less mobile and social the person became. This information can help providers to better assess and treat their patients.

Can We Measure Loneliness?

Sociability is crucial to our overall well-being and lack of social encounters are indicators of loneliness. The traditional measures of sociability are often questionnaires, patient self-tracking, the UCLA loneliness scale but all of these require participant effort and many times the report lacks enough detail to draw any conclusions.

SocialSense, an in-person social network (IPSN) is able to track real-life, in-person interactions through audio data. This tracking device is able to detect conversations, detect social scenes and context as well as turn-taking behaviors, with no content analysis to respect participant’s privacy.

The Sociability Clinical Pilot at Baylor College of Medicine (emailed waiting for confirmation) spent 1 week audio-tracking their participants, using the daily smartphone app sensor features discussed above, along with patient baseline psychometric measures.

Key Findings

A decrease in sociability was seen among patients with depression, including fewer longer conversations and fewer social contacts. The SocialSense reports were consistent with the self-reports. SocialSense was also able to detect audio self-talk conversations amongst patients with psychosis.

Conclusions

  • Most patients are willing to be monitored via technology (>80% adherence).
  • These tracking studies are among the first of their kind to study adolescents and adults who suffer from depression. They are also the first to use the new tool for psychiatry, the parent app.
  • Data from the participant’s phone sensor and usage features correlated with symptoms of depression, which was even more pronounced in the moderate to severely depressed patients.
  • The data we can get from wearables can help better evaluate a patient’s mental well-being and develop the most appropriate solutions.

What are your thoughts on the subject? How would you feel about your activities being tracked for health purposes?

Source: diabetesdaily.com

Improving the Transition from Pediatric to Adult Care for Patients with Diabetes (ADA 2020)

At the American Diabetes Association (ADA) 80th scientific sessions, Dr. Robert Zimmerman MD, Vice-Chairman of Endocrinology and Director of Diabetes Center Cleveland Clinic, and his team discussed the importance of creating a smooth and seamless transition from pediatric to adult care.

This time of transition is considered a high-risk time for patients living with diabetes. Diabetes aside, these patients are dealing with other life stressors that often emerge at this point in their life. Coming off their parent’s health insurance, going off to college or out in the workforce, and having to pay their own bills can create a lot of stress. Because of this, patients often neglect their diabetes care. Having a transition plan in place from pediatric to adult care can help these patients feel empowered and equipped to handle their own diabetes care as they become young adults.

Key Takeaways

  • Each year, thousands of adolescents with both type 1 and type 2 transition to young adults and also from pediatric to adult care.
  • The developmental stage between ages 18-30 is defined as the period of emerging adulthood.
  • Due to life stressors, this is a period where many are distracted from their diabetes care.
  • During the first phase of transition, around age 18-24, many patients feel overwhelmed and have a tendency to reject parental control.
  • During the second phase of transition, at about age 25-30, the young adult tends to take on more responsibilities in life and usually starts to place more importance on diabetes management.
  • The period of emerging young adulthood is considered a high-risk time for patients with type 1 or type 2 diabetes.

Differences Between Pediatric and Adult Care

  • Pediatric Approach
    • Family-oriented
    • Holistic
    • Visits are with both child and parents
  • Adult Approach
    • The patient is autonomous in their care
    • Individualized counseling
    • The patient makes their own decisions regarding care

Major Risks During Transition

  • Suboptimal Glycemic Control
    • Only 32% of patients between 13-18 years old met ADA goals
    • 18% of children under 18 achieved the ADA recommendation for A1c
    • 56% of adults achieve an A1c of 7%
  • Neglect of Diabetes Care
    • Older teens and young adults tend to disengage from health care
    • Both short-term and long-term complications can occur as a result of neglecting care

Factors That Increase the Risk of Hypoglycemia and DKA

  • The loss of parental guidance
  • Less frequent doctor visits
  • Work/school stressors that take precedence over diabetes care
  • Consumption of alcohol
  • Change in physical activity
  • Different dietary patterns than once had under parental care
  • Lack of motivation to stay on top of health

Patients Face Many New Challenges During This Period

  • Psychosocial challenges include worrying about the future, lack of a plan or goal in place for managing their diabetes, feeling anxiety, or being overwhelmed with care, handling uncomfortable social situations regarding diabetes.
  • Psychological issues are prevalent during this time, although these can occur at any time while managing a chronic condition. Feelings of depression, anxiety, eating disorders and suicide are all concerns that need to be addressed during this time.
  • Pregnancy is another issue that arises during this period of emerging adulthood.
    • Contraception use is lower for adults with diabetes from the age of 20-44
    • 39% of adults with diabetes do not use contraception compared to 27% of adults who don’t have diabetes
    • An increasing number of women with pre-existing diabetes are becoming pregnant and having children
    • Only 1 in 4 women with diabetes age 16-20 were aware of the risks involved with getting pregnant with diabetes and the importance of optimizing glycemic control before and during pregnancy in order to maximize the odds of conceiving and delivering a healthy baby.
  • Other health risks that can happen at any age for people with diabetes seem to be most prevalent during these years: alcohol use, illegal drugs, smoking, driving and hypoglycemia.

Current ADA Recommendations for the Transition

  • Pediatric health care provider works with the patient and parent planning for transitioning starting up to 1 year prior
  • Preparation focusing on self-management for emerging teen
  • Preparation should include the differences between pediatric and adult care and should help guide the patient on major decisions such as health insurance, etc.
  • The provider should prepare and provide a list for the patient and new adult doctor summarizing the patient’s medications, assessment of skills, history, etc.
  • Healthcare providers need to recognize all the changes during this period can lead patients to neglect care.
  • The transferring provider should provide patients with specific referrals to adult physicians that would best fit the patient’s needs.
  • The transferring physician should empower patients and provide them with any educational materials and resources that can help them to stay on top of their diabetes care.
  • Care must be specific to the patient and strive to avoid both short term and long term complications.
  • The provider must evaluate and treat emerging teens with any disordered eating behaviors or affected disorders.
  • On-going appointments should take place every 3 months for patients on insulin and every 3-6 months for patients with type 2 who are not taking insulin.
  • Screening guidelines should be followed for both microvascular and macrovascular issues as well as the management of lipids and hypertension.
  • Birth control, drug use, driving, STDs, etc. should all be discussed with the teen and their parents by both the transitioning and adult physician.
  • Both providers should make sure the patient is getting primary and preventative health care and feels comfortable with the care and support they are receiving.

Transition Options Available at The Cleveland Clinic Foundation

  • Transition clinic: here, adolescents are taught how to manage their diabetes on their own. They are then introduced to the adult care endocrinologist who oversees the patient’s care after this first visit. The follow-up with the adult endocrinologist can happen on the transition floor or at Adult Endocrinology at the diabetes center.
  • Transition shared medical visit: In this instance, a shared medical appointment takes place instead of their traditional appointment and the goal is to make the transition as smooth as possible for the patient.
  • Adult endocrinology office visit: patient goes directly to the referred adult endocrinologist.

Cleveland came up with an Autonomy Checklist which helps patients to learn necessary information that they should have while transitioning to more autonomous care.

Group Visits

Cleveland Clinic put into place group visits that take place approximately every 3 months where they have an educational speaker, review A1cs, glucose readings and insulin adjustments to engage the adolescents as well as give individual exams.

Cleveland Clinic’s Transition Recommendations Moving Forward

  • Creating flexible appointments: nights, weekends and special availability while young adults are home from college are important. Virtual appointments and classes will likely be the main way of interacting for this group. Dr. Zimmerman stated that their office went from “1% virtual visits to 75% in approximately one week’s time”.
  • Building relationships: community support groups led by a provider, monthly events and taking advantage of organizations and apps like College Diabetes Network (CDN), where they can connect with others living with diabetes is useful.
  • Transition simulation nights where young adults going off to college can go through possible scenarios and problem-solve together as a group. Questions like “my insulin fell and cracked open, where can I get insulin in the middle of the night?” or “My blood sugar suddenly is dropping, but I am in the middle of taking an exam, what should I do?” would be addressed.

Conclusion

Young adults transitioning from pediatric to adult care are a high-risk group that needs a supportive and comprehensive system in place, where caretakers understand the unique complexities of this life stage. Creating a seamless and specific transition plan will help guide these patients to achieve optimal health during these years.

Source: diabetesdaily.com

Debate: Can Technology Eliminate Hypoglycemia? (ADA 2020)

Advances in diabetes technology have brought forth a lot of new and valuable tools to people living with diabetes. From continuous glucose monitors (CGMs), to insulin pumps, to integrated systems that can automatically adjust insulin delivery based on CGM reading to safeguard against hypoglycemia, diabetes tech is rapidly evolving. For all insulin users, low blood glucose is of particular concern; too much insulin on board can quickly result in an emergency situation, if not promptly addressed.

At the American Diabetes Association (ADA) 80th Scientific Sessions, experts debated the following important question:

Can technology alone solve the problem of hypoglycemia in diabetes?

Dr. Richard M Bergenstal, MD from the International Diabetes Center at Park Nicollet argued “for”, while Dr. Emma G. Wilmot, MD from the University Hospitals of Derby and Burton present her case “against” this notion. Here is the synopsis from this exciting debate. Notably, both presenters disclosed numerous relationships with technology companies and pharmaceutical companies.

Yes, Technology Alone Can Solve the Issue of Hypoglycemia

Dr. Bergenstal began by defining four specific “problems” of hypoglycemia:

  1. “Dangerous levels and ripple effects of hypoglycemia”—low blood glucose levels can cause mental turmoil and may prevent patients from striving for optimal glycemia
  2. Defining hypoglycemia
  3. Detecting hypoglycemia
  4. Preventing hypoglycemia

We have been pretty unsuccessful at preventing hypoglycemia; that is, until technology was introduced,” he stated.

Strikingly, the presenter mentioned that after over 20 years of improvements to the average a1C levels, they are now increasing across the board. Dr. Bergenstal attributed this largely to people’s fear of hypoglycemia. He also mentioned a recent paper that indicates that, sadly, we are also experiencing a “resurgence in diabetes-related complications.”

Next, the presenter addressed the importance of consistently defining hypoglycemia. He explained that the official definitions of hypoglycemia (as defined for clinical trials reporting) have been evolving in recent years, now often defined by levels.

Then, the speaker moved forward to discuss that CGM technology was critical to the most thorough detection of hypoglycemia, noting that self-monitoring of blood glucose (SMBG, or finger-sticks) did not present the whole picture of blood glucose trends, making it more likely that low blood glucose could go unnoticed. Moreover, he argued that the accuracy of today’s CGM devices are on par with many blood glucose meters.

As far as the capability of technology in preventing hypoglycemia, Dr. Bergestal presented data from a very large international study showing that CGM use resulted in a tremendous decrease in both hyperglycemia and hypoglycemia, across a large patient population, across the board. He also presented data from several other studies that demonstrated the benefits of CGM technology as related to the incidence of hypoglycemia.

Next, he also addressed the role of “smart insulin pumps” that communicate with CGMs in helping to further reduce hypoglycemia. Strikingly, the results from one study using an “automated basal/hybrid closed loop system (closed loop at all times with meal-time manual assist bolusing)” resulted in a 100% reduction in hypoglycemia. The presenter also showed some case reports that suggested more technology (CGM + Pump vs. CGM + MDI) may yield better glycemic management. Furthermore, he touched upon several other advancements, ranging from faster-acting insulin formulations on the market and in development to smart insulin pens, and their relevance in improving outcomes (see below).

Dr. Bergenstal had this to say in conclusion:

“Technology can address [all four problems of hypoglycemia]… We’re going now from just good clinical care, to really ethics and just morality, I think. This journal of HealthCare Ethics Committee Forum, they looked at and postulated that continuous glucose monitoring is really a matter of justice. I know that sounds a little extreme, but if it can do what I’m showing you it can do, and people are struggling every day, maybe they really do have a right to use this technology… I think we better rely on technology to prevent the highs and the lows of diabetes.”  

No, Technology Alone Cannot Solve the Issue of Hypoglycemia

Dr. Emma Wilmot began by sharing that she loves diabetes technology, and that it plays an important role in reducing hypoglycemia. “However, technology ALONE can solve the problem of hypoglycemia? If only it were that simple,” she stated.

The speaker went on to present data showing that despite CGM use, as many as 25% of users are still experiencing severe hypoglycemia. She argued that “structured education” in diabetes management plays a more central role in reducing hypoglycemia, pointing to numerous research studies showing significantly improved outcomes following a formal diabetes education program.

Moreover, Dr. Wilmot commented on the role of hypoglycemia unawareness, and how reducing the incidence of low blood glucose levels via educational programs, also helped to mitigate hypoglycemia unawareness, in turn likely reducing severe hypoglycemia even more.   In contrast, she stated that there is no research to show that technology use can help to mitigate hypoglycemia unawareness. Furthermore, the presenter discussed several studies that showed “no additional benefit” of technology use (CGM and/or insulin pumps).

Technology is not for all,” Dr. Wilmot noted, citing issues like various technical problems, alarm fatigue, and site skin reactions. Strikingly, according to data from T1 Exchange, “41% had stopped using CGM in the past year.” Similarly, she noted, “30% of youth discontinued the hybrid closed-loop system”. Access and affordability is another paramount issue, she noted.

Rebuttals

While Dr. Bergenstal remarked that he understood and appreciated the role of patient education programs, he noted in his rebuttal, that the glycemic outcomes are not optimal in these patient populations, stating he believes technology can give us better control, reducing both hypo- and hyperglycemia.

Dr. Wilmot concurred that the levels of glycemia currently being achieve are “nowhere near good enough” and also agreed that several established educational programs are now incorporating technology education as well. However, she maintained that technology alone was not the sole solution.

Dr. Bergestal concurred with this, but also stated that technology is “outpacing everything else we’ve thrown at hypoglycemia so far.”

Conclusions

While most will agree that technology use can help to reduce hypoglycemia, whether it can be altogether (or even mostly) overcome with technology use alone remains a point of debate. Undoubtedly, the role of education in diabetes management plays a pivotal role. There is no “set-it-and-forget-it” in diabetes management today, not quite yet, anyway, and certainly not across the board for patients. Perhaps, as smart technology evolves further and becomes more mainstream, it may eventually overtake patient education in importance when it comes to preventing adverse events.

What are your thoughts on this subject?

Source: diabetesdaily.com

Creative Bolus Strategies Result in Better Glycemic Control (ADA 2020)

At the American Diabetes Association (ADA) 80th scientific sessions on Friday afternoon, Margaret Pellizzarri, RN, MS, MBA, CDE along with the Integrated Diabetes Services team, including Gary Scheiner, MS, CDE delivered a unique presentation on clever insulin bolusing techniques for people living with diabetes who use a pump or multiple daily injections, when dosing for high-protein and high-fat meals.

Bolus Options

  • Normal bolusing–delivers insulin all at once and is used for most meals
  • Square bolusing–delivers insulin over a period of time. This is especially useful in situations where there is a buffet or you are eating over a longer period of time. Patients with gastroparesis also can benefit from square bolusing since their digestion is slowed down.
  • Combination or dual-wave bolus–delivers a portion of the insulin as a normal bolus and the rest as an extended or square bolus. This can be particularly helpful with meals that are high in fat, high in both fat and carbs, as well as for high-protein meals.

Insulin Dosing for Protein and Fat: Studies and Strategies

Studies conducted in both people living with type 1 and type 2 diabetes indicate that fat slows down gastric emptying and slows down glucose absorption. This can result in hypoglycemia for patients after a fat-laden meal. Several studies demonstrate that both high-fat and high-protein meals require more insulin to achieve target postprandial blood glucose levels. Furthermore, glycemic responses vary depending on the specific macronutrient profile of the meal, with higher-protein meals tending to cause prolonged hyperglycemia (if not accounted for). Altogether, this indicates that the insulin delivery strategy must be optimized in dose and timing to achieve the most optimal results when consuming such meals. 

Here are the highlights from the presentation:

  • One study showed that high-protein, high-fat meals required 30% more insulin over 6 hours and suggested using a glucose meter or continuous glucose monitor (CGM) to adjust as needed.
  • Another investigation demonstrated that consuming a mixed protein mixed meal (36 g protein, 30 g carbs, 5 g fat) when dosing only for the carb content, resulted in higher postprandial glucose values. By using a protein-fat insulin dosing algorithm, they suggested that adding 66% more insulin delivered in a combination bolus over three hours resulted in improved glucose levels. The impact of a meal that was higher in protein and fat, showed to be additive to postprandial glucose levels.
  • One study showed that mealtime doses for individuals with type 1 diabetes need to be individualized. For high-fat meals (more than 40 g), patients should consider additional mealtime insulin, around 30-35% of the initial dose. For individuals using pumps, it is recommended to try a combination bolus with half the dose before eating and half delivered over 2-2.5 hours after eating.
  • One investigation suggested that high-protein and high-fat meals require a >60% ICR (insulin-carb ratio) as a standard bolus before the meal with an additional ICR up to 70% in an extended bolus starting at 1.5-5 hours after the meal.

Conclusions

  • Experts suggest altering your insulin dosing and changing the timing of insulin delivery can help better navigate tricky meals that are high in fat and/or protein.
  • Using the bolus techniques presented above, those on an insulin pump can experiment to achieve what works best (Note: If low blood glucose occurs, it is recommended to extend the duration of the remainder of the extended dose.)
  • Those using multiple daily injections can also vary the timing and dose of their insulin according to the specific meal (although this may be more tedious). You could also consider different insulin based on their activity profiles (make sure to discuss any changes with your healthcare provider!).
  • Despite the manufacturer’s recommendations of dosing insulin within 15 minutes of meal consumption or immediately after, research shows that best postprandial glycemic results are achieved when taking the specific macronutrient distribution of the meal into account and adjusting both insulin amounts and timing to best match that food profile.
  • Recent research shows that injecting 15-20 minutes before meals is safe, and results in 30% lower glucose levels and less post-meal hyperglycemia when premeal glucose levels were in range.

Whether you use a pump and can take advantage of the special bolusing features or are on multiple daily injections, there are strategies to try when consuming high-protein, high-fat meals. With some trial and error, we can all benefit these creative tactics to strive for improved postprandial glucose levels when it comes to the always challenging high-protein, high-fat meals. Be sure to always consult your healthcare provider before making any changes to your insulin dosing regimen.

***

What are your thoughts on the subject? Do you use any of these strategies? How do you navigate complex meals?

Stay tuned for more from the ADA 80th scientific sessions!

Source: diabetesdaily.com

Study Shows the Need for Intensive Telehealth Intervention in Rural Areas (ADA 2020)

Access to specialty care and intensive self-management programs can be beneficial to patients living with diabetes and can help them improve their overall diabetes management. Unfortunately, these programs are lacking in rural areas and can lead to poor diabetes outcomes for those patients. With telehealth emerging as our new normal, this gives rural areas the opportunity to have better-specialized diabetes care.

This week at the American Diabetes Association 80th Scientific Sessions, the results of a study that examined the implementation of an intensive telehealth intervention in a rural area were presented. The researchers used the infrastructure of already existing Veterans Health Administration (VHA) and Home Telehealth (HT). This study took into account that the services provided would be in addition to already receiving in-person care.

Study Methods

Elizabeth A. Kobe led the 6-month telehealth intervention for patients with “poor glycemic control” (typically an A1c>8.5%), which was earlier found to be effective in a randomized trial.

The Advanced Comprehensive Diabetes Care (ACDC) combined telemonitoring, self-support management and medication management guided by a clinician. From 2017-2019,  the ACDC was implemented in five rural VHA sites with guidance from the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Key Findings

  • A1c improved from an average of 9.25% at baseline to 7.89% at six months
  • Implementation at each site was well-received with an average of 8-10 of 12 scheduled ACDC calls complete
  • ACDC improved patient engagement and awareness of their diabetes management

Conclusions

There is no question that intensive telehealth interventions, when properly designed using already existing infrastructure, is a much-needed addition to standard care for many and can lead to improved and sustainable glycemic control improvements, especially for people living with diabetes in rural areas, who may have less access to traditional care and diabetes education approaches.

Source: diabetesdaily.com

Breaking Updates from TrialNet (ADA 2020)

TrialNet is a research effort that seeks to identify preventative and treatment strategies for type 1 diabetes. New data was just released at the American Diabetes Association (ADA) 80th Scientific Sessions. Here are the major highlights:

1. The optimal age for screening children at risk for type 1 diabetes

It is possible to screen at-risk individuals for the development of autoantibodies that are predictive of T1D development. This can reduce the likelihood of health complications due to a late diagnosis as well as allow patients to enroll in clinical trials aimed at preventing or delaying T1D onset. Researchers recently evaluated the sensitivity, specificity and predictive values based on the screening ages of children at risk for developing T1D. They concluded that it was best for two separate screenings to occur; one around the age of 2-3 years and another at around the age of 5-6 years. “Our data represent a starting point for these considerations that should be customized based on the population’s underlying disease characteristics and public health infrastructure,” they added.

2. Identifying those at risk

How do we identify those who are most at risk for developing T1D? Currently, beta cell function analysis, utilizing glucose tolerance tests and other, more invasive measures, are used. New research demonstrates that using a validated (in type 2 diabetes) mathematical tool may be able to help make this assessment for those at risk for type 1 diabetes from “fasting glucose and insulin measurements from a single time point.” This could afford a fast and relatively non-invasive way to predict risk in the future.

3. Antibody-positive individuals with very slow progression to type 1 diabetes

It is established that people can develop T1D at different rates, after the initial appearance of autoantibodies. New research aimed to characterize the features of “long-term non-progressors.” Interestingly, data revealed that those whose disease onset did not progress long after autoantibody detection, still had a decline in beta cell function, but nevertheless exhibited largely stable glucose profiles and c-peptide levels. Researchers speculate that glucose tolerance testing in those with autoantibodies may help identify those who are less likely to progress to T1D.

4. Pancreas volume and type 1 diabetes progression

New research demonstrates that not only is pancreas size at the onset of T1D and in those at risk smaller, pancreas size is also predictive of T1D risk. The study evaluated those with “stage 1” T1D (those who have two or more autoantibodies, but normal glucose tolerance) and found that their pancreas volume was significantly smaller than that of healthy controls (but significantly larger than those with “stage 3” T1D (showing autoimmunity and hyperglycemia, with symptoms). Although the sample size was relatively small, the data indicate that pancreas size (as measured by MRI) could be a predictive indicator of T1D development.

5. Oral insulin for those at risk of developing type 1 diabetes

Relatives of people with type 1 diabetes (T1D) who were identified as “high-risk” for also developing the condition participated in a prevention trial that used oral insulin (OI) in this population. While overall, the treatment did not appear to be effective in preventing T1D in initial analyses, a further analysis of patient subgroups revealed an interesting trend. Among those who were identified as being at the highest risk for developing T1D (high auto-antibody levels; hindered first-phase insulin response), data indicate that OI can “slow insulin decline”.

Read more about TrialNet and the work they’re doing here:

New Treatment Delays Type 1 Diabetes

Please share this article and stay tuned for more news from the ADA Scientific Sessions.

Source: diabetesdaily.com

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