Is Digital Diabetes Coaching Worth the Cost?

Does digital diabetes coaching really work? And is it worth the money?

While these programs were basically unknown only a few years ago, there is now a dizzying number of businesses claiming to offer personalized mobile diabetes coaching programs. A diaTribe guide to the services lists fifteen different options, a number which may only grow in coming years. (In a related phenomenon, there are also many new coaching services that utilize continuous glucose monitoring for people without diabetes).

What is digital coaching?

Digital coaching is not telemedicine or telehealth. A digital diabetes coaching service can only supplement, but not replace,  your doctor, endocrinologist, or diabetes educator. Digital diabetes coaching services cannot order prescriptions and cannot address more complicated health issues.

Digital diabetes coaching services aim to help “fill in the gaps” between regular visits with an existing care team, as a representative of MySugr, one of the better-known services, puts it:

I really see the benefits of having those touch points in between physician appointments because the day-to-day is what really matters with diabetes. If you’re just going in every several months it’s hard to make changes that stick. If you’re able to check in with a coach every so often without having to make an appointment, not only does it help the management, but it helps ease anxiety which is a huge part of diabetes too.

While the details will vary from one business to another, the basic idea is that the patient will share his or her data (blood sugar, insulin use, weight, etc) through a mobile app. The app provides feedback and advice, whether it’s delivered by an algorithm or a trained professional. Even if the mobile coach doesn’t deliver any revelations, the hope is that little check-ins and notifications will help keep patients more mindful of their condition and in a better frame of mind to apply themselves to their diabetes management, leading to improved results.

Some coaching platforms are paid for by insurers or employers. Others require patients to pay for them directly – a common price is about $50 per month.

The case against digital coaching

Digital coaching services have studies that show that their coaching programs deliver big results – improving HbA1c, weight loss, and reductions in insulin and other glucose-lowering medications. But in a recent debate at the American Diabetes Association’s Scientific Sessions conference, Dr. Kasia Lipska of the Yale School of Medicine expressed doubt about the quality of the evidence in favor of these programs.

After reviewing the clinical literature, Dr. Lipska noted that most studies of the services tend to be sponsored by the companies themselves. They are typically of very short duration, and some are barely up to good standards for clinical science.

She referred particularly to a study run by Omada Health of its own program. Among the problems with this study: no control group, no randomization (perhaps meaning that participants were highly motivated), and missing data, in addition to the obvious conflict of interest.

Omada has also run a randomized controlled trial, considered a far more thorough approach. Those results, which have only been made public in a press release thus far, were “relatively modest,” showing some weight loss but less than a 0.1% improvement in HbA1c. A similar trial, of the Noom coaching platform, had similar results, showing no difference in A1c and a relatively minor improvement in weight loss.

The best-designed study of digital coaching platforms that Dr. Lipska was able to find “did not demonstrate clinical effectiveness.”

“I think we have to squint a little bit to see a lot of evidence for clinically important significant outcomes,” she stated.

Dr. Lipska also expressed some personal skepticism about the programs.

“The thing that really bothers me is that they’re really not aligned with the healthcare team. Me as a clinician, I have no input into the feedback that my patient gets.”

The case in favor of digital coaching

Arguing the opposite case was Dr. Anne Peters, the director of the University of Southern California’s Clinical Diabetes Programs, and a much-honored diabetes advocate.

Dr. Peters took a broader view of the problems that digital coaching is meant to solve, noting that the healthcare costs of diabetes continue to spiral and that many people with diabetes still struggle to achieve the targets set by their doctors.

Even if patients enrolled in digital coaching services do not experience better outcomes, the programs may be worth the cost to insurers and employers if it helps reduce the frequency of in-person visits to the medical center. Some studies have found that digital coaching systems reduce patient medical spending and office visits, big benefits for patients, insurers, and medical practitioners alike.

Moreover, in Dr. Peters’ telling, patients can use all the help we can get them. Technology and medication have improved significantly in recent years, but they are not effective without training and professional assistance. For decades we have known that diabetes education improves outcomes – is there a good reason to doubt that education delivered through a smartphone would fail to do the same?

Both debaters agreed that digital coaching platforms were only likely to help a certain percentage of diabetes patients, those with a modicum of technical acumen and a willingness to commit to a more intensive management style. It’s possible that such patients are already highly motivated to pursue management success and are therefore less in need of help than others less likely to use such a service. While Dr. Lipska argued that this means that digital coaching services may exacerbate healthcare inequities, Dr. Peters took a more optimistic view of the matter, counting any new treatment options as a positive even if they do not serve all patients equally well.

Takeaways

Digital diabetes coaching hopes to supplement standard medical care for diabetes by filling in the gaps between visits to the doctor’s office. By offering advice and reminders, they hope to keep your mind on your condition, setting you up for diabetes management success.

The evidence in favor of digital diabetes coaching is mixed. The proof that these platforms actually lead to improved outcomes is meager, but there is better evidence that they may save money for insurers and employers that offer the programs by reducing the frequency of in-person visits.

Would a digital diabetes coaching service be worth the cost to you? For a certain type of person, especially a patient ready to take his or her glucose management to the next level and willing to keep up with frequent online check-ins, these programs may well be highly effective.

 

Source: diabetesdaily.com

Tackling Type 1 Diabetes – Where Are We on Technology and Research?

This content originally appeared on diaTribe. Republished with permission.

By Andrew Briskin

Andrew Briskin joined the diaTribe Foundation in 2021 after graduating from the University of Pennsylvania with a degree in Health and Societies. Briskin is an Editor for diaTribe Learn.

At the Milken Institute 2021 Future of Health Summit, leading experts in type 1 diabetes research and innovation discussed the path toward a cure, the latest in glucose monitoring technology, and the importance of screening for type 1 diabetes.

A group of leading experts in type 1 diabetes research and innovation took part in the panel discussion, “Tackling Type 1 Diabetes: Where the Science is Heading” at the Milken Institute 2021 Future of Health Summit last month. They exchanged insights on the advantages of continuous glucose monitoring, automated insulin delivery (AID), Time in Range for better diabetes management, as well as tantalizing new possibilities for curing type 1 diabetes.

The discussion from June 22nd was moderated by diaTribe Founder Kelly Close and included:

  • Aaron Kowalski, Ph.D. – CEO, JDRF International
  • Shideh Majidi, M.D. – Assistant Professor, Pediatric Endocrinology, Barbara Davis Center for Diabetes
  • Felicia Pagliuca, Ph.D.  – Vice President and Disease Area Executive, Type 1 Diabetes, Vertex Pharmaceuticals
  • David A. Pearce, Ph.D. – President of Innovation, Research and World Clinic, Sanford Research

The panelists began by discussing how continuous glucose monitors (CGM) now provide people with type 1 diabetes even more information and the power to manage their glucose levels. CGM data provides people with crucial metrics such as Time in Range (TIR), which corresponds to the percent of time someone spends within their target glucose range – usually 70 to 180 mg/dL. This target glucose range may vary though, for example, if you are pregnant. You can learn more about the helpful metrics that CGM provides here. Alongside A1C, TIR allows more insight into your day-to-day diabetes management by showing fluctuations in glucose levels caused by factors like meals, exercise, illness, and more.

However, CGM is not perfect or widely accessible yet. The panelists touched on this issue of access to CGM and the existing disparities in care across race and type of insurance. Dr. Majidi emphasized that in populations with access to this technology, CGM use has increased from 20% to over 80% of patients over the last five years. However, some studies have shown that providers tend to prescribe technology only to certain patients due to unconscious biases about which patients may be able to handle using advanced technology.

Advocating for early and consistent training for healthcare providers on addressing these biases, as well as provider and patient education on CGM and other technologies for glucose management, Dr. Majidi said, “we need to look at these unconscious biases to start providing everyone with the opportunity to use and learn about new technology.”

The panel then explored the advantage of AID hybrid closed-loop systems. These systems combine a CGM, insulin pump, and an algorithm that allows the CGM and insulin pump to talk to each other. Dr. Kowalski said he was especially encouraged by the advancements in AID systems, emphasizing that it not only decreases the number of highs and lows, but it also removes much of the burden of diabetes management from patients and their families.

AID systems especially benefit families with children who have diabetes, reducing concerns from parents about the safety of their children during the night or at other times when the risk of hypoglycemia is high. The panelists said they were hopeful that these new innovations are bringing us closer to developing a fully closed-loop artificial pancreas, which could automatically respond to changes in glucose in real time without the need for a person to deliver manual boluses or calibrations.

Echoing their advice on how to address disparities in CGM use, the panelists noted the importance of education for healthcare providers to combat disparities in prescribing AID to ensure equal opportunity for all to achieve better health outcomes.

The discussion then shifted to the latest research towards a cure for type 1 diabetes, focusing on beta cell replacement therapies. Because type 1 diabetes occurs as a result of the body’s immune system attacking and destroying its own pancreatic beta cells (the cells that make insulin), scientists have been researching how to replenish the beta cell population from stem cells. Scientists believe that stem cells, not yet fully differentiated or mature cells, could potentially be directed to become functioning beta cells.

Dr. Pagliuca shared updates from her work at Vertex, studying stem cell-derived beta cell transplants in type 1 patients with impaired awareness of hypoglycemia. This initial study relies on systemic immunosuppressive drugs (these are drugs that “turn off” the body’s immune system so it won’t attack the implanted cells) to protect the implanted beta cells. The hope is that future studies will seek to use a different method called encapsulation, which protects beta cells from the immune system with a physical barrier, avoiding the need for immunosuppressant medications.

So far, with the successful conversion of stem cells into mature beta cells accomplished in controlled lab settings, the science has developed to the point of testing stem cell-derived beta cells in clinical trials, with Vertex first clinical trial now enrolling patients. This initiative will encompass the entire type 1 community, with Dr. Pagliuca stressing that “transitioning these breakthroughs into the clinical phase will require participation from all stakeholders, patients, researchers, and healthcare providers.”

Considering the latest research into the immunobiology of type 1 diabetes, the panelists advocated for significant increases in screening for type 1 across the general population.

Dr. Pearce advised that testing for the presence of specific autoantibodies (small molecules in the body that are the cause of the immune system attacking a person’s own beta cells) in the general population is essential for implementing prevention programs, given that the presence of at least two of these autoantibodies is a very predictive measure to assess the risk of developing type 1 diabetes.

According to him, the predictive power of these screenings make it is possible to classify an individual as having type 1 diabetes years in advance of any symptoms, even while they still have normal glycemic control. In this way, type 1 diabetes can be classified into 3 stages – stage 1 is when someone has two or more diabetes-associated autoantibodies, but normal glycemia and no symptoms. Stage 2 is when you have the autoantibodies, have begun to develop glucose intolerance or abnormal glycemia, but still no symptoms. Stage 3 is when symptoms begin and you are diagnosed with type 1 diabetes. Classifying diabetes in this way and identifying those in the early stages could increase patient involvement in clinical trials, and help connect individuals to new drugs such as teplizumab (not yet approved by the FDA), that aim to delay the onset of symptomatic type 1 diabetes or prevent it altogether.

Drs. Pearce and Kowalski agreed, recommending a screening strategy involving primary care providers and screening children during the toddler years. On the importance of this screening process for involvement in clinical trials, Dr. Kowalski noted, “Diabetes is a global problem. The voice of the patient is hugely important on new devices and therapies, and clinical trial pathways are delayed when there isn’t equal participation in the trials.”

You can watch the panel discussion and hear insights from the four incredible experts here.

Source: diabetesdaily.com

Should More People with Type 2 Diabetes Use a CGM?

The continuous glucose monitor (CGM) has been hailed as vital technology for good blood sugar management in type 1 diabetes. But although it could provide similar benefits to people with type 2 diabetes, the expensive technology is not yet widely available for type 2 patients. 

Enthusiasm is growing for the use of CGMs for patients with type 2 diabetes, but some experts remain skeptical. And some of the critical decision-makers still need to be convinced before access will really expand.

Patients with type 2 diabetes typically experience fewer intense and unpredictable blood sugar swings than those with type 1. Only a minority of patients with type 2 diabetes have been prescribed insulin, and only a minority of them use rapid-acting insulin multiple times a day, the way that patients with type 1 require. 

Many experts are eager to give patients with type 2 a new tool to help manage their condition. And nothing would make CGM manufacturers happier than to sell their products to the type 2 market; for every patient with type 1 diabetes, there are about 20 potential customers with type 2. But scientists have yet to make the case that the CGM is so helpful to patients with type 2 diabetes that it justifies its high price.

Current Guidelines

So far, the American Diabetes Association has only recommended CGMs for patients with type 2 diabetes that are on “intensive” insulin regimens – patients that are using insulin pumps or multiple daily injections to control blood sugar levels aggressively.

It certainly makes sense for patients on intensive regimens to get the earliest access to the tech. Frequent blood sugar readings allow these patients to dose insulin for meals, exercise, and corrections far more precisely. The alarm function can be a literal lifesaver in the event of low blood sugars.

However, millions of patients with type 2 diabetes use only basal insulin, and millions more do not require insulin at all. They may not need to make multiple insulin dosing decisions every day, and may have a less critical need for low blood sugar alarms, but the device could still play a huge role in improving their glucose management.

Many people with type 2 diabetes are eager to use a CGM but cannot pay for it out-of-pocket. Some find themselves in the disheartening circumstance of knowing that they can only access this valuable technology if their control gets worse.

But a new study may help change this situation.

The MOBILE Study

Dexcom, the manufacturer of the popular G6 CGM system, recently unveiled the results of a randomized clinical trial pitting its continuous glucose monitors against traditional blood sugar meters. The studies were published in the medical journal JAMA and presented at the recent Advanced Technologies & Treatments For Diabetes (ATTD 2021) conference.

The MOBILE study looked at 175 adults with “poorly controlled” type 2 diabetes who used basal insulin but had not been prescribed multiple injections of mealtime insulin. The participants began the trial with an A1c between 7.8% and 11.5%. They were randomized into two groups: those given CGMs, and those given blood sugar meters.

After eight months, both groups had improved A1c’s, but the group using CGMs improved much more: −1.1% vs. −0.6%. On average, the CGM users spent about four more hours in range and four fewer with very high glucose (>250 mg/dL).

Those improvements appeared to apply across the board. When researchers split the study group into different subsections based on age, education level, or “diabetes numeracy,” the group using the CGM always had significantly better results than the group using fingersticks.

second study was published in the same edition of JAMA; this one observed the outcomes of patients that began using Dexcom CGMs in real life (without any intervention by the researchers). Patients with type 2 who initiated CGM use were overwhelmingly likely (97%) to be using intensive insulin regimens, just as the guidelines recommend.

The results? Type 2 CGM users improved from an average 8.2% A1c to 7.64%, an even larger improvement than patients with type 1 enjoyed in the same study. They also experienced significantly less hypoglycemia than they had previously.

Dexcom, unsurprisingly, was ebullient, describing the publication of the two studies as “a pivotal moment in diabetes care innovation.”

Skeptical Experts

Not everyone agrees that CGMs should be prescribed to more patients with type 2 diabetes. In March, Kaiser Health News argued that there is actually very little evidence that the technology does much good for most patients in the type 2 community.

The writer noted that the small number of studies of the CGM’s efficacy in type 2 diabetes have so far come up with conflicting results; several find little benefit. And while the data from the two new Dexcom studies wasn’t yet available, it might be wise not to take the results of industry-sponsored science at face value. Several of the older studies that found good results for continuous glucose monitoring were similarly organized by CGM manufacturers, including Dexcom.

Dr. Katrina Donahue, director of research at the University of North Carolina Department of Family Medicine, was one skeptical expert quoted in the article: “I don’t see the extra value with CGM in this population with current evidence we have… I’m not sure if more technology is the right answer for most patients.”

Money Talks

Price is going to be a big issue. Dexcom, Abbott, and any other competitors not only have to convince patients and doctors that the CGM is can help type 2 diabetes. They also have to convince insurance companies that it’s worth paying for.

That might be a tough job. Many CGMs users are already acutely aware of how expensive the product can be. If the benefits to patients with Type 2 that do not require intensive insulin treatment are less dramatic, insurance companies will be less enthusiastic about covering the system.

Some doctors agree. Dr. Silvio Inzucchi, director of the Yale Diabetes Center, was quoted by Kaiser Health News: “The price point for these devices is not justifiable for routine use for the average person with Type 2 diabetes.”

Short-Term CGM Use

Interestingly, the results of the two studies suggest that the improvements in glycemic control were not the result of increased insulin use but improved patient engagement. The CGM can serve as a constant gentle reminder of the importance of glucose management. Hopefully, the thinking goes, CGM users are more likely to make good eating or exercise decisions.

That finding might help support the advance of temporary CGM use for patients with diabetes. If the CGM works primarily by informing its user about the glycemic impact of different lifestyle decisions, maybe people could benefit from only a week or two of CGM use. They might learn lessons that they could put use to improve their glucose management even after ceasing to use the device.

The temporary CGM has long been rumored as the next big step for patients with type 2. Some healthcare providers already have CGMs that they will loan to patients for short-term rentals, and Dexcom has recently made its CGM available on a trial basis through its Hello Dexcom initiative.

Moving Forward

JAMA simultaneously published an editorial arguing for expanding the use of CGMs for patients with Type 2 diabetes. Authored by doctors Monica Peek and Celeste Thomas of the University of Chicago, the letter calls for “important policy changes in Medicare eligibility to CGM for type 2 diabetes and institutional changes that promote its use in primary care.”

The writers also noted that patients “from racial and ethnic minority populations, those in low-income groups, and other socially marginalized groups are disproportionately affected by type 2 diabetes,” and that improved access to CGMs could especially help the most vulnerable diabetes patients.

The MOBILE Study is just one step, but perhaps a significant one, in widening access to the CGM for the type 2 community. Advocates will hope that such data will convince the diabetes authorities, especially the American Diabetes Association, to expand their recommendations.

Source: diabetesdaily.com

Rush for COVID Vaccine Hinders Diabetes Tech Advancements

Modern science is amazing. The COVID-19 pandemic, which is still shaking the world as we know it, is quickly getting controlled due to fast scientific progress and the vaccine rollout (in the United States, at least).

Having an effective vaccine come to market within a year of the appearance of a novel disease is unheard of; most medicines take decades for adequate approval processes within the Food and Drug Administration (FDA) to be completed. This feat is incredible.

That being said, with all of the rush to get a vaccine to the masses, the FDA pushed the Pfizer, Moderna, and Johnson & Johnson vaccines literally to the front of the approval line, delaying other important medical and technological advancements, including those related to diabetes.

While the vaccine did (and should!) take precedent here, the delays have been tough for people with diabetes in many ways. 

The head of the FDA’s device center, Jeff Shuren, described a “tsunami” of product applications from companies hoping to join the fight against the COVID-19 pandemic.

Those applications include over 1,200 submissions for products like diagnostic tests, ventilators, and digital technology, all of which have slowed their work in other diseases, including diabetes.

Shuren went on to say that review times had begun to increase amid growing backlogs due to the high volume. 

The agency is trying to make as much space as possible to approve COVID-19 related vaccines, medicine, and technology quickly to end the pandemic, which has taken precedence over almost everything else. Experts suspect that the FDA may not be able to meet its own timelines going forward.

In addition, lockdowns and social distancing regulations halted clinical trials and product releases. It’s been a tough year for diabetes tech firms to get much done.

The following products, and their release dates, have been most affected by the pandemic:

Senseonics’ 180-Day Eversense Glucose Monitor

The Eversense continuous glucose monitor (CGM) is a device implanted under the skin that lasts for 90 days. The newest version of their CGM system aims to double its lifespan to 180 days without changing a sensor.

What was supposed to be released in early 2021 now faces delays of up to two months for its application to the FDA while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices. The new release date of the model is scheduled for mid-2021.

The Omnipod 5 (Originally “Horizon”)

Insulet’s Omnipod 5 system, which utilizes CGM data to make automated adjustments to basal insulin throughout the day, will be the company’s first hybrid-closed loop system.

Similar to the T-slim Control IQ system, this insulin pump will provide mobile app control and insulin dosing from a smartphone, eliminating the need to carry their hallmark Personal Diabetes Manager (PDM) around to control the release of insulin.

While significantly delayed due to the COVID-19 pandemic, Insulet said during its Nov. 4, 2020 investor update call that it had recently finished its clinical trial and was finalizing its FDA submission.

They hope to launch their product by June of 2021.

Medtronic 780G

Also known as the Advanced Hybrid-Closed Loop (AHCL) system, this system will improve upon its first iterations of the hybrid-closed loop system, the 670g and 770g. Hoping to seek approval for adults and children as young as two, this system includes:

  • A CGM sensor that will require just one calibration on the first day of wear and no further calibrations after that
  • Automatic correction bolus delivery every 5 minutes, in conjunction with CGM readings, that can automatically bolus for missed meal doses.
  • A lower glucose target range, adjustable between 100-120 mg/dL
  • Different insulin duration times, to adjust for the “tail” of your insulin (eg, Fiasp vs. Humalog)
  • Built-in Bluetooth to share data and provide remote software updates

Due to the pandemic, the approval for this device has been delayed, but Medtronic confirmed that it had submitted its application for review to the FDA in February, 2021.

They hope to have a commercial launch sometime in 2021.

Dexcom G7

The much-anticipated Dexcom G7 continuous glucose monitor (CGM) was also delayed due to the pandemic, but it should be worth the wait. You’ll no longer need to buy separate transmitters; each sensor is a complete and disposable transmitter/sensor integrated system. Some other great features include:

  • No calibrations, much like the G6
  • At the start, wear time will be 10 days, but eventual use will include a 14-15 day feature, also without any calibrations
  • Smaller and thinner: the newest CGM will be 60% smaller than the G6
  • One hour warm-up period

Dexcom CEO Kevin Sayer said that the company eventually plans to have different versions of the G7 for different people.

For example, people with type 2 diabetes who don’t use insulin (or even the general public) might opt for a much simpler interface than people with type 1 diabetes, who will want all of the alarms and settings.

Abbott Freestyle Libre 3

For years, the FreeStyle Libre from Abbott Diabetes was a considered Flash Glucose Monitor (FGM), because it only reported blood sugar levels whenever a user scanned their sensor with a receiver or smartphone.

That will change with the new edition: The Freestyle Libre 3 will function as a real-time CGM, because it won’t require sensor scanning to get a “flash” of blood glucose data. It will instead provide trends and graphs to track blood sugars throughout the day.

The Libre 3 generates real-time blood sugar readings every minute (as opposed to Dexcom’s every 5 minutes), displaying the result on a mobile app on your smartphone. This version also has optional high and low blood sugar alarms, a feature introduced with the Libre 2 in 2020.

Additionally, the sensor is much smaller and thinner (a 70% size reduction), and is kinder to the earth, using 41% less plastic overall.

The Libre 3 received global approval in September 2020. The timeline in the US has been pushed backwards, but with clinical trials now complete, we’ll likely see the Libre 3 applications submitted to the FDA mid-2021.

While the hustle for an effective COVID-19 vaccine has been nothing short of miraculous, people with diabetes don’t want to wait any longer!

Hopefully, with the hastened release of the vaccine, we can see more diabetes technology hit the market in 2021. 

Source: diabetesdaily.com

So You Got a CGM – Now What?

This content originally appeared on diaTribe. Republished with permission.

By Katie Mahoney, Hanna Gutow, and Diana Isaacs

If you just got a continuous glucose monitoring system, you may be wondering how to use it most effectively and how to understand your glucose data. Read our tips, tricks, and things to consider.

Congratulations – you got a continuous glucose monitor (CGM), an excellent tool to support diabetes management. Hopefully you’re feeling optimistic and excited that you have the opportunity to use this technology.

It’s most likely that you and your healthcare team decided that using a CGM is the optimal way for you to manage your diabetes. Perhaps you were given a prescription for a personal CGM. Or maybe you’re trying CGM as part of Dexcom’s Hello Dexcom program (a free ten-day trial), through Abbott’s MyFreestyle program (a free 14-day trial), or as part of Medtronic’s CGM Discount Access program. You might also be trying professional CGM, which is owned by your healthcare clinic and worn on a short-term basis.

If you haven’t yet been able to get CGM, ask your healthcare team if you can get a trial device or get a prescription. CGM is recommended for anyone with diabetes who takes mealtime insulin. While many people with diabetes currently don’t have access to CGM, we’re hopeful that more and more individuals will be able to use this technology in the future. Regardless of what brings you to using a CGM, we’ve created a three-part guide to help you get started, including tips, tricks, and considerations.

Click to jump down to a section:

Part 1: Before you apply your CGM

Learn the basics.

Before you start using your CGM, it can be helpful to understand its basic features. Continuous glucose monitors (CGM) measure the body’s glucose (or sugar) levels by sensing the glucose present in tissue fluid (also called interstitial fluid). While a blood glucose meter (BGM) provides a measurement of the blood glucose level at a specific moment in time (when you prick your finger), CGMs provide a new glucose level every one to five minutes – depending on the device, that’s 288 to 1,440 times per day. A CGM provides a constant stream of information on glucose levels, trends, and patterns.

A CGM can either be transcutaneous (it goes through your skin) or implanted (it lies under your skin). CGMs require three basic parts:

  1. A sensor that monitors real-time glucose levels under your skin.
  2. A transmitter that sits on top of the sensor and sends glucose information to a smartphone app, reader, or receiver. In transcutaneous systems, the sensor and transmitter are connected as one small on-body device. Some transmitters are disposable with the sensor while others require an additional step to attach. In implanted systems, the transmitter is attached to the skin and can be removed without harming the sensor below the skin.
  3. A smartphone app, reader, or receiver to collect and display your data.

CGMs have a variety of features that differ by brand and model, including the amount of time the CGM needs to “warm up” before glucose readings are available, how long you can wear a CGM sensor before needing to replace it, and alarms that alert you to highs and lows. You can learn more about CGM devices here. For brand-specific resources and information, click here to jump down.

Personal CGM vs. Professional CGM

The CGMs that we just described are called personal CGMs – they are owned by the person with diabetes and used for a long period of time. They are available as real-time CGMs, where the data can be continuously viewed, or as intermittently-scanned CGMs, where information is recorded all of the time, but you need to scan the sensor to view the data.

Another type of CGM is called “professional CGM.” Professional CGMs are given to someone with diabetes for a short session (usually one to two weeks) to better understand that person’s glucose levels. After the wear period, the person will review the data with their healthcare professional. This can provide insights that inform the person’s diabetes treatment, and it can help healthcare professionals recommend therapy and lifestyle recommendations that lead to better glucose management.

Some professional CGMs have a real-time mode, meaning that the user can see their glucose levels while wearing the device. Other professional CGMs have a “blinded” mode. Blinded CGM means that you cannot look at their glucose values on-demand; instead, all of your glucose data is stored and shared with your healthcare professional. This can help your healthcare team identify hypoglycemia (or low blood sugar levels). If you get a blinded professional CGM, your healthcare team will analyze the data and discuss it with you once your wear period is complete.

While long-term, real-time CGM is most effective for day-to-day diabetes management, especially for insulin users, professional CGM can be an important tool for people who are not using personal CGM. Periodic use of CGM can help people learn the effects of food and physical activity on glucose levels, even for those not taking any diabetes medications.

Reflect on your goals, know your targets, and make a plan to respond to highs and lows.

It can be helpful to reflect on your CGM goals, set your glucose targets, make plans for responding to your glucose readings, and decide with whom you want to share your data:

  • Reflect on your CGM goals. Perhaps you want to use CGM to prevent hypoglycemia using its alert system, or to prevent hyperglycemia and increase your Time in Range, or to manage glucose during exercise. Or, maybe you and your healthcare team are going to use professional CGM for two weeks to explore how your lifestyle habits affects your glucose levels. Regardless, the ultimate goal of CGM is to improve your diabetes management.
  • Know your personal glucose targets and make a plan with your healthcare team for how you’ll respond to hyperglycemia and hypoglycemia. Knowing your target glucose range is important for responding to your real-time glucose values. For most people with diabetes the target range is 70-180mg/dl – learn more about Time in Range goals here. Make a plan that incorporates glucose trend arrows from your CGM to help you prevent big spikes out of range. Here are some prompts for you to discuss with your healthcare team:
    • What is my glucose target when I wake up and before meals?
    • What should my glucose level be two hours after a meal? If it is above that value, what actions should I take to bring my glucose levels down?
    • What is my glucose target before bed?
    • What high glucose level should I try to avoid? What should I do if my glucose gets that high?
    • What low glucose level should I try to avoid? What should I do if my glucose gets that low? What should I do if my glucose levels are trending down?

Part 2: Applying your CGM

Connect the CGM to the app and set the system up.

Download the mobile app associated with your CGM system if available. If you’re using a receiver (Dexcom device) or reader (Libre device), make sure it’s charged daily. The CGM should come with instructions for applying the sensor (every seven, ten, or 14 days) and pairing the app, reader, or receiver with your sensor and transmitter. If you have an implanted CGM, it will be applied by a healthcare professional and can last up to 90 days. To jump to brand-specific instructions and tutorials, click here. To learn about CGM adhesives and tips for keeping your CGM on, check out Adam Brown’s suggestions on the topic.

Once your system is set up, your CGM will need to “warm up” before you can see your data. Different models have different warm-up periods, but this will generally take one to two hours, after which your data will be accessible either directly (Dexcom, Guardian, Eversense) or by scanning your sensor (FreeStyle Libre). The warm up period for the implantable Eversense system is 24 hours.

For many people starting to use a CGM, video tutorials can be quite helpful. If you have the opportunity, it’s good to meet with a diabetes care and education specialist or your local pharmacist (if picking up your CGM from a pharmacy). Here are set-up and application tips and tutorials for your CGM:

Part 3: Understanding your CGM data

Once you’re set up with your CGM and the warm up period is complete, you can access your data. There are two types of data you’ll want to pay attention to: real-time data and past data.

Interpret your real-time data.

Depending on the CGM brand you’re using, you can either access your glucose data at any time by looking at an app on your phone, your smart watch, or your receiver. For those using an intermittently-scanned CGM, you can view your glucose levels by scanning your sensor with your smart phone or reader. Looking at your data can feel overwhelming at first, so we recommend focusing on two aspects of your real-time data:

  • First, look at your CGM glucose value. Is it in your target range? If your glucose level is out of range, which steps of your plan should you follow?

If you’re experiencing hypoglycemia in particular, make sure you act right away to increase your glucose levels.

  • Second, look at the trend arrow. Your CGM provides a “trend arrow,” to tell you the direction and speed with which your glucose values are changing. The trend arrow is helpful for understanding what’s going on and how you can respond. For example, if your glucose value is 90 mg/dl and your trend arrow shows that your glucose levels are going down, you may need to take action to prevent hypoglycemia; if your glucose value is 90 mg/dl and your trend arrow shows your glucose levels are increasing, you are likely not going to develop hypoglycemia.

Trend arrows can help with premeal insulin dosing, before and after exercise, before bed, and to understand where your glucose will be trending in the next 30 minutes. Trend arrows are particularly beneficial when used with insulin on board (short-acting insulin that was recently taken for food or to correct a high glucose level and is still working in the body). For example, if your trend arrows are going down and you have insulin on board from an insulin dose given two hours previously, your risk of hypoglycemia is even greater.

For those not using insulin, trend arrows can help understand how different foods and activities affect glucose levels. For example, if a person sees that the arrow is rising rapidly after a certain meal or snack, they can go for a walk to try to bring it down. It may also signal that next time you should consider a smaller portion size or try to add protein or fat to prevent glucose levels from rising as quickly.

Each CGM has a slightly different interpretation of the arrows, but here’s a general idea of what the trend arrows can tell you.

data

Image source: diaTribe

We recommend working with your healthcare team to decide how often to check your glucose levels. Many people benefit from checking glucose when waking up, before meals, before physical activity, and at bedtime. Some people benefit from checking one to two hours after meals. A person should also check their CGM any time they feel symptoms of high or low glucose. CGM alarms are especially helpful for monitoring glucose levels as they change – more on this below.

Interpret your past data.

Once you’ve used your CGM for a few days, you can see your recent daily trends and the amount of time you’re spending in the target range (70-180 mg/dl). This is also called retrospective data. It is beneficial to review your glucose data regularly to understand how your lifestyle – like the food you eat, your exercise habits, your stress levels, and medications you use – affects your glucose levels. Look at your glucose levels over the past two weeks, one month, and three months; talk with your healthcare team about trends that you are noticing and how they might be addressed. Learn about the many factors that affect glucose here.

During diabetes care appointments, your healthcare team can view this data in an Ambulatory Glucose Profile (AGP) report and use it to talk with you about how your diabetes management is going and any potential adjustments to your care plan. This should be a collaborative discussion between you and your healthcare team about how your diabetes data compares to your management goals and what changes could be made.

Each CGM system offers a standardized one-page report, called an ambulatory glucose profile (AGP). The AGP includes three important components:

  1. CGM key metrics
  2. 24-hour profile
  3. Daily glucose patterns

Although there are many ways to view your glucose data, the AGP report often has all of the information that you need. We’ll explain the three main pieces below. To learn more, read our in-depth piece on understanding your AGP report: “Making the Most of CGM: Uncover the Magic of Your Ambulatory Glucose Profile.”

CGM key metrics

More green, less red.

The time in range bar shows the percentage of time you spend in five glycemic ranges:

  • data

    Image source: diaTribe

    Time in Range: glucose levels between 70-180 mg/dl

  • Time Below Range: glucose levels below 70 mg/dl
  • Time in severe hypoglycemia: glucose levels below 54 mg/dl
  • Time Above Range: glucose levels above 180 mg/dl
  • Time in severe hyperglycemia: glucose levels above 250 mg/dl

Your goal is to grow the green bar and shrink the red bars – in other words, increase Time in Range and decrease time Below Range and time in severe hypoglycemia. See more on Time in Range goals and standard targets.

24-hour profile, also known as Ambulatory Glucose Profile (AGP).

chart

Image source: diaTribe

How do you figure out how to change your diabetes management to increase your Time in Range and decrease your Time Below and Above Range? That’s where the 24-hour profile is helpful, which shows your daily glucose trends across the full 24-hour day.

  • Understanding what the 24-hour profile shows: The black line represents your median glucose level throughout the day based on data from a set period of your CGM use (e.g., the last two weeks). The blue shaded areas help show how much your glucose levels vary at different points in the day.
  • Using the data: Compare different times of day to see what might be influencing your glucose numbers. For example, while the person shown above has glucose readings that vary greatly at 3pm (indicated by a very wide shaded area), their 8am glucose numbers are much more consistent (the shaded area at 8am is narrower), despite being higher. This person also regularly sees a spike in sensor glucose readings at around 9am. What’s causing that increase? Maybe it’s a higher carbohydrate breakfast choice, forgetting to bolus, not bolusing early enough, or not accounting for all the carbs in breakfast. Reflecting on what is causing a spike or valley can help you make behavior changes to reduce fluctuations and increase your Time in Range.
  • chart

    Image source: diaTribe

    The goal: The overall goal is to keep your glucose levels in your target range without big spikes or valleys, sometimes called “flat, narrow, in range” (FNIR). In the AGP above, the green box represents the user’s target sensor glucose range (70-180 mg/dl). While the user stays in range overnight and in the afternoon, they tend to see spikes in the morning and evening. With the goal of FNIR in mind, you can look at your long-term data and ask, what’s making it possible for me to stay in range? What is making my glucose spike or fall?

  • The good news is the goal for most people is to spend 70% or more Time in Range. However, increasing your Time in Range by even 5% (an extra hour per day in range!) can be helpful. You don’t have to reach perfection to improve clinical outcomes.

Daily glucose profiles.

With your trend data, you also can see your daily 24-hour glucose profiles from the last two weeks. The figures show the target range (70-180 mg/dl) in gray, spikes above 180 mg/dl (hyperglycemia) in yellow, and valleys below 70 mg/dl (hypoglycemia) in red. Viewing the data day by day can help you evaluate how specific factors and behaviors impacted your glucose values on a certain day.

data

Image source: diaTribe

To make the most out of your daily glucose profiles, it can be helpful to log your daily food and exercise to compare with your glucose profile and see which behaviors help you stay in range and which ones tend to make you go out of range.

A helpful tool when reviewing your data with your healthcare team is called DATAA. Which stands for:

  • Data – look at your diabetes data together
  • Assess Safety – Look for and try to solve Time Below Range (hypoglycemia) first
  • Time in Range – Discuss what’s working and how to replicate that by looking for the times of day or the days of the week when Time in Range was the highest
  • Areas to Improve – Note when you spent more Time Above Range (hyperglycemia) and discuss ways to reduce this
  • Action Plan – Develop an action plan together

Other Tips, Tricks, and Considerations

1. Exercise & your CGM

To learn about how to use your CGM before, during, and after exercise, check out our article “Exercise Well with Your CGM – Recommendations, Glucose Trends, and Strategies.”

An important note about exercising with a CGM: There can be a difference between CGM glucose measurements and BGM glucose measurements due to what we call a “lag.” Changes in glucose levels in interstitial fluid are not seen as quickly as they are in the blood. At rest, the interstitial glucose lags about five minutes behind the blood glucose; in situations when glucose changes rapidly, such as during exercise, lag time can increase up to 24 minutes. This means that your CGM readings aren’t always going to be accurate during exercise. This lag can also occur outside of exercise, any time your glucose levels are rising or falling quickly.

2. How to make CGM alarms your friend

Adam Brown has written about how it can be helpful to think about your CGM as a partner in your diabetes management, rather than a nag that points out when you’re not in range. Alarms can be useful tools. By alerting you to current or predicted highs and lows, as well as rate of change, you can increase your Time in Range and see your 24-hour glucose profile become flatter, narrower, and more in range. You can personalize your CGM alarm settings to your preferred thresholds or turn them off completely (though some devices won’t let you turn off an urgent low alarm at 55 mg/dl). It’s helpful to work with your diabetes care team to determine your individualized alarm settings.

3. Sharing data with friends, family, and care-partners

The ability to share your real-time glucose data with your care-partners and loved ones is a huge plus of using CGM – your support network can help you track your glucose levels and keep them in range. At the same time, sharing your data with others makes some people nervous and self-conscious. Decide who you want to share your data with and talk with that person about boundaries and how you want to communicate about your data. For more on how to approach these conversations, check out Kerri Sparling’s “To Share or Not to Share: My Approach to Diabetes Data,” and “How to Coach Your Care-Partner on CGM Data.”

4. How to talk to your healthcare team about your CGM

Now that you’re using a CGM, talking with your healthcare team about your CGM data should become a key part of every visit.

Ahead of the visit: To help visits go smoothly, many healthcare professionals will ask you to upload your CGM data before you come into the office (or before your telehealth appointment) so they can review the data and be prepared to talk with you. Learn about uploading your data here. Note: some CGM systems upload automatically once connected to the clinic’s data portal. It’s also helpful to look over your data – like your AGP report – and come up with questions to ask your healthcare professional ahead of the visit. You may have questions about parts of your daily glucose profile that you don’t understand, areas where you’re having a hard time staying in range, or just general questions to help you navigate your data.

During the visit: To make sure that you and your healthcare professional are on the same page, it can be helpful to take a few minutes at the beginning of your appointment to explain your interpretation of your data in your own words. This may be a good time to start a conversation on any questions you may have prepared ahead of your visit. It is also important to take time with your care team to develop an action plan based on your CGM data with a few straightforward priorities for you to focus on before your next visit.

Brand-Specific Resources

While any CGM can help improve your diabetes management, there are some differences between the currently available systems that you may want to consider or talk about with your healthcare team – see our chart comparing different CGMs here. Specifically, we recommend asking your healthcare professional about how alarms may be able to alert you to times of hyperglycemia or hypoglycemia, what it means if you have to calibrate your CGM, and how to use your CGM with smart insulin pens, mobile apps, or even insulin pumps in an automated insulin delivery (AID) system.

To reach out to CGM companies for product support, contact their customer service departments:

  • Abbott: +1-855-632-8658
  • Dexcom: +1-888-738-3646
  • Medtronic: +1-800-646-4633
  • Senseonics: +1-844-736-7348

This article is part of a series on Time in Range.

The diaTribe Foundation, in concert with the Time in Range Coalition, is committed to helping people with diabetes and their caregivers understand Time in Range to maximize patients’ health. Learn more about the Time in Range Coalition here.

Source: diabetesdaily.com

Breakthroughs in Pancreatic Cell Replacement: The ViaCyte Interview

I recently had the opportunity to sit down with Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development, and Mark Daniels, Senior Director of Clinical Development, of ViaCyte, “a regenerative medicine company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for all type 1 diabetes and a next-generation treatment for insulin-requiring type 2 diabetes.”

They have amazing things coming down the pike, so I was super excited to speak with them:

Tell our readers about ViaCyte. What’s the company’s mission and story?

Dr. Jaiman: ViaCyte is at the forefront of regenerative medicine approaches to develop a functional cure for type 1 diabetes (T1D). We have cell replacement therapies for pancreatic islet cells contained in a small retrievable pouch implanted under a patient’s skin.

The therapy is designed to enable insulin and glucagon (the counter-regulatory hormone that treats low blood glucose) production with the implanted cells to effectively control blood glucose levels, decrease the risk of hypoglycemia, and mitigate short-term and long-term diabetes-related complications for patients.

What is exciting is that ViaCyte is the first company to advance human stem cell-derived islet cell replacement therapy capable of producing insulin in the clinic, backed by two decades of research and expertise.

We are further augmenting our therapies by optimizing both the delivery device and the cells through collaborations with industry leaders, including W. L. Gore & Associates (the makers of GORE-TEX) and CRISPR Therapeutics.

Our mission is to develop cell replacement therapies offering long-term treatment to decrease the burden of the constant management needed with T1D.

What led you to your work at ViaCyte?

Dr. Jaiman: A significant focus of my medical career has been the integration of technology and medicine to advance treatments that can change the paradigm of diabetes disease management.

My experiences both in research and actively seeing patients with T1D have given me first-hand experience in seeing the daily work required to achieve any form of glycemic control as well as the burden patients and families face from complications from hypoglycemia or DKA.

I have also been able to see the importance of innovative approaches in addressing their needs. When I looked at the ViaCyte technology, I immediately saw great potential in their regenerative medicine approach to lessen the burden of disease and improve quality of life.

Mr. Daniels: Throughout my time in the industry I have been extremely fortunate to be able to work with innovative companies advancing potential, game-changing therapies for difficult-to-treat diseases. I was attracted to ViaCyte because the bar is set high; ViaCyte is looking to develop functional cures for diseases and is not just treating symptoms.

I also believe in the potential of cell replacement therapies and that these will be a meaningful new chapter in the advancement of medical treatments.

In ViaCyte, I have also found a team of extremely gifted and dedicated scientist-coworkers who are all generous with their knowledge and completely aligned in the mission to deliver a functional cure to the type 1 diabetes community.

It is exciting to be the first company to evaluate human stem cell-derived islet cell replacement therapy for its potential to functionally cure type 1 diabetes in the clinic.

Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development and Mark Daniels, Senior Director of Clinical Development

Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development and Mark Daniels, Senior Director of Clinical Development

What exciting new developments is ViaCyte currently working on?

Dr. Jaiman: Currently, ViaCyte has two clinical cell replacement therapy candidates. First, VC‑02 PEC-Direct is a treatment comprised of pancreatic islet cells in a pouch designed to allow blood vessels to enter the device and directly interact with the implanted cells to produce insulin and glucagon.

This treatment candidate is targeted for those with high-risk type 1 diabetes (hypoglycemia unawareness) able to tolerate immunosuppression.

In contrast, our groundbreaking VC‑01 PEC-Encap device is an advanced treatment comprised of pancreatic islet cells in a pouch that fully encapsulates the cells preventing immune cells from interacting with the implanted cells, which eliminates the requirement for immunosuppressants.

We are collaborating with W. L. Gore & Associates to optimize their innovative membranes which encapsulate the cells in our implanted devices. We expect to share clinical data in the second half of 2021.

Anything new in the pipeline that people with diabetes should be especially excited about?

Dr. Jaiman: One of the challenges with cell replacement therapies is to protect against adverse reactions and rejection of implants by the body’s immune system, which serves as a defense mechanism against foreign bodies.

In collaboration with CRISPR Therapeutics, we are employing gene-editing technology to engineer cells to avoid recognition by the immune system. Our partnership is focused on advancing gene-edited allogeneic stem cell-derived therapies from discovery through commercialization with the goal of developing a potential next-generation functional cure for all insulin-requiring type 1 and type 2 diabetes.

Mr. Daniels: With our preclinical candidate, VCTX210 PEC-QT, pancreatic islet cells would be in the same pouch as PEC-Direct, allowing the implanted cells to interact directly with blood vessels, an approach intended to enable robust and consistent engraftment.

Yet by designing the cells to be immune-evasive through CRISPR Therapeutics’ gene editing we would expect to eliminate the need for immunosuppressants as are required with PEC-Direct. We look forward to sharing more about this unique program in the future.

Photo credit: ViaCyte

Where do you envision ViaCyte and people’s lives affected by diabetes in five years? Ten years?

Mr. Daniels: This year marks the 100th anniversary of the development of therapeutic insulin to regulate blood glucose, yet dependency on tedious insulin injections are still a common course of treatment for many living with type 1 diabetes.

Within the next five years, we envision delivering significant progress in later clinical-stage studies with increased time in range, reduction in hypoglycemic events, and reduction in (or elimination of) the need for insulin injections in patients following our cell replacement treatments as we move toward making these therapies more widely available.

Dr. Jaiman: Within five years, we expect to be moving through the final phases of our regulatory process for our human stem cell-derived islet cell replacement therapy enabling availability more broadly for patients with type 1 diabetes.

It is our hope that within a decade, cell replacement therapy will offer longer-term treatment, easing the burden of constantly monitoring blood glucose. A functional cure will no longer be a dream, rather, a reality.

Is the ever-elusive cure on the horizon? A functional cure?

Dr. Jaiman: Yes, we believe a functional cure is on the horizon!

ViaCyte is focused on advancing cell replacement therapies toward a functional cure with a combination of implanted cells and device engineering.

This cell replacement therapy could represent insulin production protected from the immune system in a way that totally mitigates the underlying disease. Our technology is designed to safely implant the missing cells that make insulin and glucagon – that’s the breakthrough that gets us to the functional cure.

How can people with diabetes get involved or learn more?

Mr. Daniels: As ViaCyte is advancing novel treatments for type 1 diabetes, our team has been very fortunate to collaborate with multiple incredible research and advocacy organizations, including the Juvenile Diabetes Research Foundation (JDRF), Beyond Type 1, and California Institute for Regenerative Medicine (CIRM).

These organizations are focused on education and support for finding a cure for diabetes with resources for both patients and researchers on their websites. A great resource is the website www.clinicaltrials.gov – by typing “ViaCyte” into the search window, you can find more details regarding our ongoing clinical trials.

This includes details about the entry criteria to participate as well as the geographical locations of the sites (to find the one closest to you) and contact details necessary to reach out and connect with the study site team to learn more about what is involved in the study participation.

Photo credit: ViaCyte

Anything else you’d like to share?

Dr. Jaiman: Insulin treatment has largely transformed type 1 diabetes from a fatal illness to a chronic one, yet it is not a cure. At ViaCyte we recognize the long journey in the evolution of diabetes management, and we are keen to deliver a solution that offers real hope for a functional cure for type 1 diabetes.

Every single member of our team is passionate and dedicated to this endeavor. Managing diabetes can be difficult at any time, however, this past year has highlighted the need for accelerating therapeutic advancements to help reduce COVID-associated morbidity and mortality in the vulnerable population with diabetes.

With the pandemic still ever-present, we believe our mission of realizing a functional cure is even more critical for patients as they navigate living with a chronic disease during this very trying time. Our leadership team is wholly focused on improving patient care with an eye to the future.

Mr. Daniels: I am very appreciative of the Diabetes Daily team for providing this forum to connect to their community. The stories of family member’s and loved one’s experiences (including those of some of our own coworkers) with T1D resonate clearly within us and fuel our motivation behind the work we do.

It is only through the support of the T1D community and especially the valued study participants that we are able to advance this important research.

We are proud to be part of the biotech and biopharma community advancing some of the world’s most promising medical devices and therapeutic treatments. We look forward to sharing more details regarding the value of these treatments in the clinic.

Source: diabetesdaily.com

Global Survey on Do-it-Yourself Artificial Pancreas System (DIYAPS)

By Saskia Wolf, Communication and Dissemination Manager, OPEN

Please support a research study by and for people with diabetes!

At the moment, OPEN is conducting a GLOBAL SURVEY and needs the support of the Diabetes Online Community; this means we need YOUR support. If you are a person with diabetes or a parent/caregiver of one, please participate, whether you are using a DIYAPS or not! More Information is provided on the OPEN website, as well as FAQs and tutorials: https://open-diabetes.eu/open-survey

We all know that diabetes is difficult to live with. It’s all on you to keep yourself alive, and to avoid the chronic effects that won’t present for many years. And no, it’s not easy to just “be disciplined” and keep your blood glucose in a healthy range!

People with diabetes sometimes need help, but not in a paternalistic sense that interferes with daily life. Besides a supportive healthcare professional team and loving family and friends, what does help look like?

For many years, proprietary medical devices were the only help people with diabetes had to manage their condition. Continuous glucose monitors and insulin pumps took a lot of the burden (and pain) away from managing diabetes, but they had limitations. Devices couldn’t talk to each other and had to be manually set; this “open loop” system lacked automation.

Because of these unmet needs, patients developed their own closed-loop systems. Yes, patients — software developers, engineers and other tech-savvy people as part of the #WeAreNotWaiting movement. They created algorithms, made devices talk to each other, and ended up with an automated insulin delivery system that automatically adjusts insulin delivery based on glucose levels to prevent going too high or low. These systems are free and open-source; despite the challenges in building them, the number of people using a “Do-it-Yourself Artificial Pancreas System” (DIYAPS) is steadily increasing.

Users of these systems report tremendous improvements not only in their HbA1c levels, but also in their quality of life. They can finally get a break from managing their diabetes, as well as sleep through the night without CGM alarms or fear of their glucose levels getting too low. But are these systems as life-changing as they sound? What are the barriers for people to build their own systems?

Some healthcare professionals are skeptical; scientists prefer academic studies to social media posts, and thus far most studies have only had small cohorts. There was a need for a concerted research project, led by scientists, clinicians, and users of a DIYAPS alike. This was the genesis of the OPEN Project EU.

The OPEN Project has received funding from the EU Horizon 2020 RISE program to investigate various aspects of DIYAPS, working directly with patients and healthcare professionals. Please visit our website for further information on the project, our team and our publications, follow us on Twitter and visit our Facebook page (@OPENDiabetesEU) and subscribe to the newsletter.

Thank you very much!

Source: diabetesdaily.com

Real Stories, Real Data, Real Results – Using Your CGM to Improve Time in Range

This content originally appeared on diaTribe. Republished with permission.

By Matthew Garza

In this video on understanding your ambulatory glucose profile (AGP) report, pediatric endocrinologist, Dr. Amy Criego from the International Diabetes Center, uses real-world AGP examples to show how small steps and manageable goals can lead to more Time in Range. 

Continuous glucose monitors (CGM) are an amazing tool; the data they provide can help you learn more about your diabetes and dramatically improve your diabetes management. You can work with your care team to improve your Time in Range (TIR) based on data from your CGM. The International Diabetes Center’s Ambulatory Glucose Profile (AGP) report is a standardized, single-page report included in your CGM software that is based on your last 14 days of glucose data. It shows key measurements – including TIR, a summary glucose profile, and daily glucose graphs – that can be used to assess your diabetes management and outcomes and inform any changes you should make.

In this video, Dr. Criego shares real-world AGP reports from three people with diabetes:

  • Lee is a 20-year-old who has had type 1 diabetes for seven years. He currently uses a blood glucose monitor and insulin injections and his A1C is usually high. He struggles with consistent monitoring of his glucose levels, especially due to an unpredictable schedule.
  • Joe is a 17-year-old who has had type 1 diabetes for 11 years. He has been using a CGM for a long time and is working to increase his independence with his diabetes management.
  • Jill is a 10-year-old who has lived with type 1 diabetes since the age of two. She uses a CGM, and though her parents currently give her insulin injections, the family is interested in exploring insulin pumps to see how they could help her diabetes management.

Dr. Criego discusses how each individual’s care team used data from their AGP report to set attainable goals that could be achieved by making small adjustments to their diabetes management. Even though these examples focus on people with type 1 diabetes, you can definitely still learn from them if you have type 2 diabetes – and be sure to watch Dr. Anders Carlson’s video which includes examples for people with type 2 diabetes.

To learn more about the AGP, check out “Making the Most of CGM: Uncover the Magic of Your Ambulatory Glucose Profile.

Watch our other videos in the “Shedding Light on the AGP Report” series:


Listen to this video at your leisure or fast forward to the section that most intrigues you!

  • 0:00 Introduction
  • 0:33 Analyze Your Report and Improve Your TIR
  • 0:56 The Different Parts of the AGP Report
  • 2:00 What is Going Well and Where are You Now?
  • 2:37 Learning from Lee – How seeing your glucose data can help improve issues caused by inconsistent monitoring by taking small steps towards achievable goals
  • 7:00 Learning from Joe – How understanding your TIR metrics can help teens gain confidence in independent diabetes management
  • 11:33 Learning from Jill – Looking at your AGP report to see how an insulin pump can help with hypoglycemia unawareness and TIR
  • 15:09 When Should You Call Your Care Team?
  • 16:42 Closing Remarks

This article is part of a series on Time in Range.

The diaTribe Foundation, in concert with the Time in Range Coalition, is committed to helping people with diabetes and their caregivers understand Time in Range to maximize patients’ health. Learn more about the Time in Range Coalition here.

Source: diabetesdaily.com

Dexcom Share Etiquette

Life is safer than ever for people with diabetes; continuous glucose monitors, hybrid closed-loop insulin pumps, faster-acting insulin, and more accurate carbohydrate counting and precision medicine have saved thousands of lives and make the day-to-day with diabetes easier than ever.

One element of that technology that has been a godsend for parents and loved ones of people with diabetes is Dexcom Share. This feature of the G6 Dexcom continuous glucose monitoring (CGM) app allows the patient to share their glucose data with up to 10 other people, who receive all glucose levels, trends, and alerts to their cell phones 24 hours a day. But what is lifesaving for some seems too intrusive for others.

This article will outline Dexcom Share etiquette and what you should do if you’re in a sticky Share situation.

The CGM Revolution

Continuous glucose monitors save lives. What was unheard of only a decade ago is now ubiquitous in the diabetes community. Many people (thanks to widespread private insurance coverage and Medicaid expansion covering this expensive equipment in more states than ever) with diabetes wear these sensors on their skin, giving them up to 288 blood glucose readings per day.

More and more of these systems do not require calibrations, so kids and adults alike are more free from constant finger pricking, unpredictable blood sugars, and stubborn HbA1c levels without an apparent cause.

CGMs make life with diabetes easier, more predictable, and more manageable for patients and their caregivers. First introduced with the G4 Dexcom system in 2015, the Dexcom Share app has been revolutionary in that it allows loved ones of people with diabetes follow their blood sugars and be alerted to both high and low levels at all hours of the day.

It seems like a simple solution for kids, teenagers, and adults who may struggle with hypo-unawareness or to just act as a second set of eyes on an all-too-often complicated disease, right? Wrong.

Diabetes Is Personal

Diabetes and blood glucose data are personal. Some people are super open and accessible about their diabetes, but others are not. A 19-year-old away at college may be shy about sharing all of her blood sugar data with a new boyfriend, or she may be trying to exert her independence and prefer not to have her mom constantly texting her, asking if she’s treating her midnight low.

And while it seems counterintuitive (why wouldn’t we have as many safeguards in place as possible?), letting (mature) kids and teens learn to manage their diabetes on their own and step into their autonomy is important for growth.

While the feature is absolutely vital for younger children and people who suffer from hypo-unawareness, if you have a child or teenager who is very independent, mature, managers their diabetes well, and isn’t comfortable with the Share feature, it’s worth the conversation and shows you respect them if you’re open to not utilizing it. Ultimately, the decision is up to the person living with diabetes, and remember, people have been thriving with diabetes for decades before this technology ever even existed.

Safety Comes First

There are, however, caveats. If you’re struggling with open communication with your teenager, your loved one suffers from hypo-unawareness, or your child is traveling for the first time without you, the Share feature is an excellent way to stay alerted to overnight lows, stubborn highs, or worrisome trends that may need addressing.

It’s important to also remember the reason for the Share app: to better equip people with diabetes and their loved ones to protect the health and safety of the person living with diabetes. It’s not to nag, hassle, or judge them for their actions (or inactions).

Share followers should not criticize or belittle someone’s blood sugars; there are no “good” or “bad” blood sugars. Blood sugars are just information directing someone to what they need to do next (like take insulin, exercise, or eat something to treat a low).

The Share app is simply one more tool one can employ to improve their diabetes management and nothing more.

Tips for a Less Intrusive Share Experience

If the person with diabetes in your life is begrudgingly allowing you to follow their blood sugars via Share, here are some tips you can employ to make the experience less intrusive:

  • Always have a discussion with your child or teenager if you’d like to follow their blood sugars with the Share app. Do not hide it from them. They will find out.
  • Set the high blood sugar alarm high and the low blood sugar alarm low. If you set your follow alarms to go off at 160 and 80, your phone will constantly be buzzing, and you’ll constantly be texting your child/teenager asking them if they’ve taken their insulin or treated their low. Really only set alarms for safety, not to be a bother.
  • Use Share for a trial period. Test the system out, and if it’s stressing both of you out, turn it off for a while before trying it again.
  • If you notice your loved one is running particularly high or low, do not comment on trends unless they ask for advice or if they have an Endocrinologist appointment coming up, adjustments can be made then unless it’s threatening their health.
  • Do not text them to see if they’ve treated their high or low blood sugar unless it is jarringly so. If they are 78 mg/dL after exercise, you don’t need to tell them to drink juice, but if they crash in the middle of the night at a slumber party and their blood sugar is 39 mg/dL, it’s best to call immediately to make sure they’re okay.
  • Make this a fun, learning experience! Praise them for the progress they’re making, and remember, with diabetes there is no perfection.
  • Respect their boundaries, and if their thoughts and feelings on Share change overtime, revisit the topic and decide how you’d like to proceed together.

Everyone with diabetes is different, and their care and management will be too. Some people are more private about their blood sugars, while others enthusiastically request input from other people on advice and tips for improving their levels.

Allowing the Dexcom Share app into your life is a great privilege, but it shouldn’t be taken advantage of. Using it as a tool to help improve your loved one’s health and diabetes management can come with great benefits if approached with caution and a heavy dose of respect.

Do you utilize Dexcom Share for your loved ones, or do you share your blood sugars with family and friends? What boundaries have worked best for your situation? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

Upcoming Apple and Android Watches to Include Glucose Monitors

In 2015, when Apple first launched its smartphone “watch”, or “smartwatch” people all over the world flocked to the new device, but it clearly became evident that the most popular feature (besides telling time), was health and fitness tracking. Suddenly, literally within arm’s reach, users had the ability to not only track their steps and mileage but to track floors climbed, standing time, moving time, heartbeats per minute (HBM), electrocardiogram monitoring, and even check for atrial fibrillation (AFib), among other things.

Apple CEO, Tim Cook, had initially suggested that they would be cautious in adding medical tracking to the watch, as approval from the Food and Drug Administration (FDA) could slow innovation.

“We don’t want to put the watch through the FDA process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it, maybe an app, maybe something else,” Cook said.

But customer demand for health tracking proved unmatched, and the company decided to change its mind, slowly adding more and more health tracking capabilities with every new version of the watch.

It should come as no surprise that according to a report out of South Korea, the newest Apple Watch, the Series 7 as well as the newest Samsung Galaxy Watch 4 (both of which are slated to launch later this year) will feature continuous glucose monitoring, developed in partnership with MIT, as people with and without diabetes alike are finding a constant watch on their blood sugars to be extremely beneficial to one’s health.

Both watches promise a “no-blood sampling method” to detect blood glucose levels using an optical sensor, and the feature will be advertised to those with and without diabetes. Unlike popular continuous glucose monitoring devices like the Freestyle Libre or Dexcom, these watches will rely on non-invasive detection of blood glucose levels, which can be achieved via infrared sensors.

Since this technology would be truly groundbreaking, it would be all but impossible to launch without FDA approval, which means that both watches would have to face several clinical trials before being available for public consumption. Clinical trials take a lot of time and money and can mean delays in a launch, especially if the glucose-sensing technology is non-invasive (which has not been seen yet, especially for people with diabetes who rely on this technology to successfully manage their diabetes).

There are many doubters, including the CEO of Valencell, an optical heart rate sensor company, who stated in 2017 that non-invasive blood glucose tracking “would never happen”.

“It is completely impossible to have a truly non-invasive glucose monitor,” Valencell CEO Steven LeBoeuf said.

Additionally, unleashing this kind of technology for mass-consumption could have unintended consequences: Will high demand for the product raise or lower the price? Will people with diabetes be priced out of their lifesaving durable medical equipment? Will blood sugar monitoring become the newest “it” thing? Will companies like Abbott and Dexcom go out of business? Will test strips eventually be a thing of the past? Will health insurance companies be mandated to cover smartwatches eventually? Will smartwatches eventually loop with insulin pumps for automatic insulin delivery? Will this be a good thing or a bad thing for the diabetes community? Is it even possible to have reliable blood glucose readings without invasive technology, interstitial fluid, or blood samples?

Can two of the leading technology companies prove all of the doubters wrong? Can people with (and without!) diabetes finally be able to track their blood sugars without invasive tactics, and achieve better control, all through a smartwatch? Can Tim Cook and Samsung CEO Ki-Nam Kim prove everyone wrong? A lot seems to be in store for the latter half of 2021, so we will just have to wait and see!

Do you monitor your blood sugars from a smartwatch? How would having your smartwatch double as a continuous glucose monitor (CGM) help you? Do you see any negatives to such a device? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

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