Memorandum

Endocrine Society and Avalere Health launch HypoPrevent, a primary care quality improvement study to reduce hypoglycemia in older adults with type 2 – August 6, 2019

Two-pronged intervention comprised of screening tool to identify hypo risk and clinical decision support tool to facilitate shared decision-making between patients and HCPs

The Endocrine Society and Avalere Health have just announced they are partnering to launch HypoPrevent, a primary care quality improvement study that aims to reduce hypoglycemia in older adults (age 65+) with type 2 diabetes.

The study began enrolling patients in June 2019, and the two-pronged intervention is comprised of (i) a screening tool that identifies older patients at risk for hypoglycemia; and (ii) a clinical decision support tool that facilitates shared decision-making between patients and providers to reduce risk of hypoglycemia. Participants are patients with type 2 diabetes age ≥65 who are on insulin, sulfonylureas, or both. To be eligible for the study, patients’ baseline A1c must be below 7%, which represents tight glycemic control. We’re very surprised the enrollment criteria are this limited given so many others face major risk of hypoglycemia despite being “at goal” – in fact, research has found that hypoglycemia occurs at equal frequency despite an individual’s A1c and whether it’s above or below target (in other words, higher A1c does not protect against hypoglycemia at all).

The decision support tool in HypoPrevent will determine if patients have “appropriate” blood sugar goals based on their other conditions that factor into an illness burden. This will help providers reduce or adjust medications, which is a major win for overworked endos, diabetologists, and PCPs. That said, we hope providers aren’t pushed to raise or loosen glycemic goals as the first strategy to mitigate hypoglycemia risk (since again, higher A1c does not lower hypoglycemia risk on its own); rather, we’d love to see the decision support feature of HypoPrevent encourage best practices in medication management for hypoglycemia control and the use of technology (i.e., CGM) to prevent lows when feasible.

Notably, this intervention follows a 750-article review on type 2 diabetes and hypoglycemia performed by the Endocrine Society and Avalere Health last year, which found that a lack of clinical resources increases hypoglycemia in US adults with type 2. We feel sure this is also true (even more) for type 1, although the focus of the present effort is clearly type 2.

As part of their broader Hypoglycemia Prevention Initiative, the Endocrine Society has also formed a technical expert panel to develop quality measures focused on healthcare processes, outcomes, patient perceptions, and organizational structures to reduce risk of hypoglycemia in outpatient settings. This panel will allow providers to identify areas for improvement, track success of efforts, and ultimately, reduce hypoglycemia. We’re thrilled to see more resources developed for HCPs, and hope to see this integrated into their workflow in an easy-to-use manner to ensure the intended benefits for patients.

  • We learned more about the program’s goals recently in a discussion with Dr. Jeffrey Boord, the Chair of the Steering Committee that developed the Hypoglycemia Prevention Initiative. He stated that the intervention strives to reduce population risk for hypoglycemia in people with type 2 diabetes on insulin and sulfonylureas by engaging with primary care providers (who provide the bulk of diabetes care – more than 90%) and developing evidence-based quality indicators for ambulatory patients. As no certified hypoglycemia outpatient quality care measures currently exist, Dr. Boord said that the initiative wants to establish these to measure performance and drive improvement. This is fantastic from our view. He also emphasized that high-risk patients need to have resources to assure they receive necessary attention in clinical settings – we see this as a big ask because there are so many reasons why patients of all kinds (not just high risk) don’t get the appropriate attention. He hopes that the results of this study will show the benefit of individualized treatment approaches and give tools to help both patients and providers manage type 2 diabetes with reference to potential comorbid conditions. More information on the initiative and quality collaboration can be found here and here.

  • We’ll be interested to see how the clinical decision support tool in HypoPrevent may dovetail with the nascent ideas we have recently heard about de-intensifying treatment. As part of a broader push on individualization of glycemic targets, the Endocrine Society this year published clinical practice guidelines promoting simpler medication regimens and looser glycemic targets for people over age 65 with diabetes. At last year’s ADA Summit on Therapeutic Inertia, we heard Leicester’s Dr. Kamlesh Khunti point to the overtreatment of type 2 in older adults and the failure to de-intensify as part of the larger problem of therapeutic inertia that can add to hypoglycemia risk in this population. Yale’s Dr. Kasia Lipska has also been a prominent advocate on this front regarding less stringent A1c targets in older patients. Although we appreciate the emphasis on individualizing targets, we do believe there is some meaningful risk that these recommendations could have unintended consequences if primary care providers interpret them too broadly and potentially adopt them in patients at lower risk for hypoglycemia. Along with individualizing pharmacotherapy treatment, we would love to see HypoPrevent’s clinical decision support tool emphasize the benefits that CGM may have in this population in terms of reducing hypoglycemia risk. The Endocrine Society said it does not see “all individuals with type 2 needing CGM.” Presumably they do believe that all people with type 2 on insulin deserve CGM; we further believe all people with type 2 on SFUs deserve CGM due to significant hypoglycemia risk and that everyone with diabetes should use intermittent CGM at least once a year . Though there are not guidelines on this yet, given so many people not at their glycemic targets, the data from intermittent CGM would enable data to be produced and assessed can help them and their HCPs better understand how their medicine is working, as well as nutrition, exercise, etc.  

  • More attention on de-intensifying treatment plans is positive where appropriate, though we also believe that patients often just are not on the appropriate treatment. For example, they take SFUs rather than glycemic-dependent incretins or SGLT-2s that do not prompt hypoglycemia. Or, they do not have access to CGM with alarms that could alert them to hypoglycemia. Notably, the ADA, Endocrine Society, and researchers have long advocated for personalized diabetes goals – we’d love to see more focus here through better targeting of appropriate therapeutics and more focus on nutrition, behavioral health, and exercise. The ADA recently recognized the need for individualization of glucose goals in its updated hypoglycemia suggestions, while the Endocrine Society’s clinical practice guidelines promote simpler medication regimens and looser glycemic targets for people over age 65 with diabetes (positive for those that need looser glycemic targets such as those on mealtime insulin with lots of severe hypoglycemia despite CGM, etc.). Back in 2016, we heard Yale’s Dr. Kasia Lipska’s opinions on tight A1c targets for elderly patients doing more harm than good – we don’t think it is wise to generalize on this front. Rather, every patient deserves therapy and technology that can keep them healthy as well as advice on nutrition, stress, exercise, and other factors that will improve their well-being.  

 

--by Ursula Biba, Martin Kurian, and Kelly Close