For digital diabetes care, is it always better to have more data?


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DDigital behavioral health programs make a bold pitch to payers, employers and patients themselves: Pay upfront for our virtual coaching and remote monitoring, and we’ll save you money by avoiding complications. costly diabetes and other long-term illnesses.

For diabetes, which nears the top of the list of chronic health problems in terms of cost, many virtual programs encourage continuous blood sugar monitoring as part of this promise. “We’ve just started to see that with CGMs it stands to reason that they’re going to be the dominant solution,” said Sean Duffy, co-founder and CEO of digital healthcare company Omada Health. The devices, which broadcast users’ blood glucose data throughout the day, are most often used by people who need multiple doses of insulin per day to manage their diabetes, but “it’s not just for people who inject insulin, ”Duffy said. “We decided that these would be table stakes and Omada needed to fuel CGM and train in a very deep way.”

However, virtual care companies do not yet have the data to support this strategy. Not all diabetic patients will benefit from wearing a device that tracks their blood sugar day in and day out. The growing adoption of CGMs, however, will provide a test. Over the past few years, many programs have partnered with manufacturers to install sensors in the arms and stomach of more patients with type 2 diabetes, including those who do not use diabetes. ‘insulin. In 2019, Omada partnered with Abbott which offered FreeStyle Libre prescriptions to some members diagnosed with type 2 diabetes, as well as a wireless scale. Livongo partnered with Dexcom in 2020 to integrate its CGM data into its program; the same year, UnitedHealth Group launched Level2, offering users coaching as well as a free Fitbit and Dexcom G6.

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The emerging data could help digital healthcare companies determine the value of CGMs, both to patients and to their outcomes.

Some programs aim to synthesize glucose data into trends, algorithmically determining a change in habit that could prevent a user from diving into dangerous glucose territory overnight, or preventing them from increasing their levels too much. high. “Sometimes it can feel like data overload,” said Tejaswi Kompala, endocrinologist and clinical program director at Teladoc, owner of Livongo. “Users don’t often look back, to examine patterns and trends. So the company ‘pushes’ users when they notice significant changes in their blood sugar. Others simply pass the data on to trainers or diabetes educators for one-on-one help by matching food, medication, and activity information with blood sugar readings like time in range.

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Some research suggests that continuous blood sugar monitoring may strengthen an app-based approach to disease management. At the American Diabetes Association’s annual scientific session in 2021, Onduo published a study of nearly 800 users of its digital diabetes program, with and without intermittent use of CGM. CGM users saw a greater decrease in blood sugar over six months than non-CGM users. Among users with elevated A1C, the decrease was 2.8%, compared to 1.8% among non-CGM users.

But the groups were not screened for differences in age, onset of A1C, or insulin use, meaning the larger drop in A1C could be attributed to more serious disease and therefore more room for improvement. And while research generally shows that health care costs rise and fall with A1C levels, the link between the impact of specific CGM-based programs on A1C and cost savings compared to d other interventions is less clear. Studies funded by device manufacturers highlight economic benefit for using CGM in patients with type 1 diabetes – with decreases in A1C potentially saving $ 3,000 to $ 7,000 over three years in one analysis – but research on the cost-effectiveness of type 2 diabetes is more limited.

This means that not all digital diabetes care companies are fully involved in CGMs. “We think CGM is for everyone,” said Henrik Berggren of digital diabetes clinic Steady Health, which was acquired by primary care provider Carbon Health in June 2021. “But the reality today is that these devices are still quite expensive, ”starting at $ 150. at $ 400 a month out of pocket. Insurance regularly only covers devices intended for diabetic patients on an intensive insulin regimen. Until Steady was acquired by Carbon, it focused its programs on patients for whom CGM was reimbursed.

Virta, a virtual program that provides nutritional support for a ketogenic diet, is also conservative in its approach to devices. “We’re very focused on results, and for what we’re doing, which is vendor-led nutrition to reverse type 2 diabetes, CMM is not required,” said CEO and co-founder of Virta, Sami Inkinen. While the Virta program can ingest CGM data if users already have a device, its default is to use finger glucose readings.

“We get the same end result with either technology,” said Inkinen. “It’s a bit faster and there is less trial and error if you’re on a CGM; it helps to have this feedback loop. But it’s hard to quantify what that would be worth in dollars. I would never say that at a price point it’s better to prick your finger three times a day than just having accurate CGM data. But it is certain that the type 1 market price is not justifiable for the whole of the type 2 population. “

What proportion of the type 2 population could then benefit from CGMs? And at what doses? “How often you use CGM in an individual should be, in fact, individualized,” said Anne Peters, who heads USC’s diabetes clinical programs and has counseled both Omada and Livongo.

In his practice, Peters uses CGMs in patients with type 1 and type 2 diabetes, including those not on intensive insulin regimens, both to titrate drugs and to help patients understand the impact. of their behavior on their blood sugar. “But I don’t think we need to have people who are stable and who do a great job continuously,” she said. “There are different ways to use CGM, and I think we need to look at that. “

Research designed to analyze the results for different models of CGM use is minimal. “There really is a gap in the evidence regarding the right cadence and the right amount of wear on CGM for people with type 2 diabetes,” said Jennifer Layne, senior director of medical affairs and clinical research at Onduo.

To understand whether CGMs make a significant difference for patients with type 2 diabetes – the users most targeted by this type of disease management apps – some companies are investing in internal research that can help determine which modes wear are the most useful and profitable. “Onduo is in a really good position to ask these questions, do this research and get this data,” Layne said.

“One of the things we want to think about is the different models of using CGM and the different types of calendars, and really start looking at populations where we can look at short and long term blood sugar results,” said Erich Huang, who joined Onduo as its Scientific and Innovation Director in June 2021.

Livongo is also studying different models of intermittent use of CGM among Type 2 users. After the company was acquired by Teladoc in a 2020 deal worth $ 18.5 billion, it has launched a pilot program with Dexcom to extend free CGM access to certain people with type 2 diabetes who were not heavy insulin users. Now it tracks patient engagement, clinical outcomes, and financial outcomes for some of those users with varying CGM usage.

“The goals of course are to want to understand the clinical outcomes, can we improve people’s blood sugar control through this intermittent use of CGM,” Kompala said. “And then, what can we understand about the dose of CGM, the frequency of CGM… What can we learn about what makes the experience of wearing CGM the most meaningful? “

As these companies struggle to determine how best to deploy CGMs, the research behind the overall value of their platforms is still in question. Some studies suggest that digital behavioral interventions can improve patient outcomes, but their value over other models of care is still unproven, as argued by Yale School of Medicine endocrinologist Kasia Lipska. during a debate at the American Diabetes Association meeting last year.

But she acknowledged that app-based platforms have responded to a significant failure in diabetes care. As endocrinologists and primary care providers work to stem the tide of diabetes, many are struggling to make an impact with the standard four 15-minute appointments they might have with a patient each year.

“Our care has been so cut in terms of the time you spend with patients,” said Lipska, “that these companies are really filling that void.”

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