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

New Research: Hybrid Closed-Loop System Outcomes (ADA 2020)

Technology is truly changing the lives of many people with diabetes across the world. Advancements continue in many areas, including the development and testing of various automated insulin delivery systems.

The MiniMed 670G insulin pump system is the first of it’s kind in providing automatic insulin delivery adjustments based on continuous glucose monitoring (CGM) data. Now, two recent research studies, the results of which were just presented this weekend at the American Diabetes Association (ADA) 80th Scientific Sessions, are highlighting the positive outcomes of the system for young and adults patients.

Outcomes in Adult Patients

Dr. Stephanie Kim, MD, MPH, from the University of San Francisco, CA, presented the results of a single-center research study in adult patients with type 1 diabetes. The researchers enrolled 52 patients (47% female, average age 46 +/-12 years, average diabetes duration of 27 +/- 15 years) utilizing the Medtronic 670G system and started “Automode” delivery of insulin between 2017 and 2019, in an effort to evaluate the impact of automatic delivery on glycemic outcomes.

The study subjects were stratified into two groups, depending on baseline blood glucose levels (defined as A1c level of higher than 7.6% or lower than or equal to 7.5%). The A1c levels were evaluated at baseline (before starting Automode) and again approximately 17 months after starting Automode.

The data revelated that while the A1c level did not change significantly in patients in the lower A1c cohort, there was improvement in the group with baseline A1c>7.6%. These patients improved their A1c, on average, from 8.3% to 7.8% using this system.

Outcomes in Youth

Dr. Goran Petrovski, MD, PhD, of Sidra Medicine in Qatar, reported on the results of an observational study of children and young adults with type 1 diabetes who used multiple daily insulin injections (MDI) and switched to the MiniMed 670G hybrid closed-loop system. A total of 42 patients (ages 7-18, mean age 12 years) were enrolled in the study.

Excitingly, the study outcomes demonstrated considerable improvements to the average A1c levels (8.4% at baseline to 6.7% at 3-months follow-up, and 6.9% at 6-months follow-up) after initiating the hybrid closed-loop system therapy. Also, the time-in-range (defined in this study as blood glucose levels between 70-180 mg/dL) improved considerably with the use of this technology. Notably, no instances of diabetic ketoacidosis (DKA) or severe hypoglycemia were reported. The authors declared no conflict of interest and concluded that “children and adolescents with T1D can successfully initiate the HCL system, achieve and maintain better glycemic control than previous MDI regimen.”

Petrovski et. al. (Presented at ADA 2020)

Conclusions

Technology that can help people with diabetes better manage their blood glucose levels continues to improve. Notably, while the glycemic improvement in youth who transitioned from MDI to the automated system were considerable, the improvements were much more modest in the study on adults using this system who switched to Automode. Altogether, the data highlight the potential of technology to improve outcomes, while also revealing that technology use (at least as it stands today) is generally not enough on its own, to achieve optimal results. Patient education regarding diet, exercise, and the numerous intricacies of dosing insulin remain central to optimizing outcomes.

Source: diabetesdaily.com

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