Issue: December 2020
Disclosures: Buckingham reports he receives grant support from Convatec, Insulet, JDRF, Medtronic, NIH and Tandem. Gabbay is chief scientific and medical officer for the American Diabetes Association. Levy reports she has received research support from Abbott, Dexcom, Insulet, Tandem, the Helmsley Foundation, JDRF and the NIH. Nally reports she has received salary support from the NIH and product support from Dexcom for research purposes. Shah reports he has served on advisory boards for Medscape and Sanofi, and received research funding from Abbott, Dexcom, Eli Lilly, Insulet, JDRF, the NIH, Novo Nordisk, Sanofi, T1D Exchange and vTv Therapeutics.
December 18, 2020
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Advanced diabetes technology poised to play larger role in care, management

Issue: December 2020
Disclosures: Buckingham reports he receives grant support from Convatec, Insulet, JDRF, Medtronic, NIH and Tandem. Gabbay is chief scientific and medical officer for the American Diabetes Association. Levy reports she has received research support from Abbott, Dexcom, Insulet, Tandem, the Helmsley Foundation, JDRF and the NIH. Nally reports she has received salary support from the NIH and product support from Dexcom for research purposes. Shah reports he has served on advisory boards for Medscape and Sanofi, and received research funding from Abbott, Dexcom, Eli Lilly, Insulet, JDRF, the NIH, Novo Nordisk, Sanofi, T1D Exchange and vTv Therapeutics.
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Diabetes technology continued to advance in 2020, and the pace of change is accelerating.

Even with unprecedented shifts in health care delivery brought on by the COVID-19 pandemic, the FDA this year cleared expanded indications for a smart insulin pen, a next-generation continuous glucose monitor and an interoperable insulin pump, allowing a customized automated insulin delivery system. In December 2019, the FDA authorized marketing of the Tandem Diabetes Care Control-IQ interoperable, automated insulin dosing algorithm, the first dosing controller that can be used with other interoperable diabetes devices. The move has been praised by experts as part of a new era of diabetes technology.

“As someone who has worked in the field of diabetes for many years, we don’t usually talk about game changers every year. But this year, we are,” Robert Gabbay, MD, PhD, FACP, chief scientific and medical officer for the American Diabetes Association, told Endocrine Today. “This is lessening the burden of having diabetes. That is a goal we are all striving for. It is challenging to have diabetes, and we ask more and more of our patients. To have technology where we are actually asking less of them, wow.”

“Game changing” diabetes technology is allowing physicians to ask for less effort from their patients with diabetes, according to Robert Gabbay, MD, PhD, FACP.

Photo by Christi Gabbay. Printed with permission.

The latest iterations of popular diabetes devices — smaller and longer-wearing sensors for CGM, “smarter” insulin delivery systems and advanced decision-support tools using artificial intelligence technology — are likely to be rolled out with greater frequency as the pace of change quickens. The ongoing COVID-19 pandemic, which pushed an almost overnight reliance on telehealth for care, only served to underscore the importance of advanced technology, according to experts; endocrinologists, in particular, now look to diabetes devices more than ever before to help patients manage glucose levels and guide decision-making.

“Things in diabetes technology are now moving like smartphones — every September, you expect to see a new iPhone — and in the diabetes field, that is going to be the expectation, that you see something new,” Viral Shah, MD, associate professor of medicine and pediatrics at the Barbara Davis Center for Diabetes and the School of Medicine at the University of Colorado Anschutz Medical Campus, told Endocrine Today. “People never imagined that things would move this fast. To say there will be something new every year, that is a huge change, and it is a move in the right direction.”

Hybrid closed-loop advancements

In January, Tandem Diabetes Care announced the commercial launch of its t:slim X2 insulin pump with Control-IQ technology, which combines the Dexcom G6 CGM with an insulin pump to regulate insulin levels with little user effort. It is the first system that adjusts basal insulin levels and delivers automatic bolus doses to prevent hyperglycemia or hypoglycemia.

In June, the FDA cleared an expanded pediatric indication for the t:slim X2 interoperable insulin pump, lowering its indicated age for use by children from 14 years to 6 years.

“The first big splash this year was the approval of Control-IQ, which came out in December 2019,” Carol J. Levy, MD, CDCES, clinical director of the Mount Sinai Diabetes Center and investigator in the NIH-sponsored study, told Endocrine Today. “That offered many new clinical features. The Medtronic 670G was a great initial device to be released, but this system is incrementally more robust for several reasons. No. 1, no finger-stick calibrations are required to make sure the device works appropriately. No. 2, the system provides automated correction doses when needed during the day. No. 3, the system allows the entry of sleep/wake cycles to maximize glucose control at different times of day. And No. 4, the system allows for extended bolusing for higher-fat meals, improving meal dosing flexibility for some patients.”

In September, the FDA approved the Medtronic MiniMed 770G system, a next-generation hybrid closed-loop insulin delivery system for children aged 2 to 6 years with type 1 diabetes. The 770G system, which builds on the success of Medtronic’s 670G, is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from users or their caregivers; it is the first legally marketed device that can automatically adjust insulin delivery based on CGM for a young pediatric population.

Viral Shah

Medtronic is launching the 770G first as a separate device, with plans to release the full-featured 780G in the U.S. Medtronic secured a CE mark for the 780G in Europe in June. In the U.S., the 780G is for investigational use only.

In the FLAIR study, the first randomized, crossover study to a compare the MiniMed 780G with the 670G, adolescents and young adults with type 1 diabetes reported a greater reduction in daytime hyperglycemia and greater ease of use with the next-generation model. The findings, presented at the ADA Scientific Sessions in June, showed participants’ time spent with glucose levels above 180 mg/dL fell from a mean of 42% at baseline to 34% and 37%, respectively, when using the 780G and the 670G, for a difference of three percentage points (P < .001).

Within the cohort, 56 participants received the 780G for 12 weeks and 57 participants received the MiniMed 670G for 12 weeks, before switching to the other device.

Percentage of time in range, defined as a blood glucose levels between 70 mg/dL and 180 mg/dL, increased from a baseline level of 57% to 67% with the advanced hybrid closed-loop and 63% with the 670G. The number of participants achieving the international time-in-range consensus target of greater than 70% went up nearly threefold from baseline when using the advanced hybrid closed-loop compared with increasing almost twofold when using the 670G.

“Each one of these systems offers different advantages, and each one is improving with each generation,” Bruce A. Buckingham, MD, emeritus professor of pediatrics and endocrinology at Stanford Children’s Health Center, Stanford University, and the Lucile Salter Packard Children’s Hospital, told Endocrine Today. “The new MiniMed system is a nicely aggressive system. It has a glucose target down to 100 mg/dL. If the active insulin time is set to 2 hours, a lot of people achieve close to 80% time in range. When that is available with a nonadjunctive sensor, and there is Bluetooth connectivity so parents can have remote monitoring, that is a significant advance.”

Buckingham presented pilot study results at the ADA Scientific Sessions this year from the Omnipod 5/Horizon automated insulin delivery system (Insulet), which employs a tubeless, on-body waterproof pump with an embedded algorithm. The pump receives communication by Bluetooth from a Dexcom continuous glucose sensor. The algorithm has customizable glycemic targets from 110 mg/dL to 150 mg/dL, which can be programmed to vary throughout the day. Users experienced a blood glucose level less than 70 mg/dL less than 1% of the time and had a mean time in range 70mg/dL to 180 mg/dL more than 70% of the time. A pivotal multicenter study for submission to the FDA has now been completed, Buckingham said.

“We use the pod for a lot of children, particularly younger children, since it is waterproof, is not ‘tethered’ and has an automatic inserter, so the child never sees and insertion needle,” Buckingham said.

Bruce A. Buckingham

Work on a bionic pancreas is also moving forward. In December 2019, the FDA granted breakthrough device designation to Beta Bionics’ investigational iLet bionic pancreas system. iLet is a pocket-sized, wearable medical device designed to autonomously control glucose levels with on-body wear similar to an insulin pump, according to the company. Unlike insulin pump therapy, however, the investigational system is designed for users to enter only their body weight for the bionic pancreas to initialize therapy, with no need to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections.

The bionic pancreas is designed to function as three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas or a bihormonal bionic pancreas using insulin and glucagon.

“Right now, we are limited in where we can set targets for blood glucose levels and how to individualize those targets,” Laura M. Nally, MD, FAAP, a pediatric endocrinologist and instructor of pediatrics in the division of pediatric endocrinology at Yale University School of Medicine, told Endocrine Today. “With diabetes, your settings need much more fine-tuning than what we are currently able to do. That is why many people move to the do-it-yourself [closed-loop insulin delivery] world, because you can individualize targets for exercise, menstrual cycles, sick days, etc. The next step for these hybrid closed-loop systems is to learn what your needs are and respond without the person with diabetes intervening.”

Next-gen CGM, sensors

Six personal CGM options are currently available in the U.S. from four companies: Abbott’s Freestyle Libre Flash CGM, Dexcom’s G5 and G6, Medtronic’s Guardian Connect and Guardian 3, and the Eversense implantable CGM (Senseonics).

In September, Abbott announced its next-generation FreeStyle Libre 3 received a European CE mark. The newest CGM features the smallest, thinnest CGM sensor — the size of two stacked pennies, according to Abbott — as well as a more environmentally sustainable system design and the longest-lasting, self-applied CGM available at 14 days (vs. 10 days with other CGMs). The newest device will be priced the same as previous generations, according to Abbott.

“I look forward to when the Libre 3 makes it to the U.S., as well as the other devices now in development from other companies,” Levy said. “Glucose sensors have different bells and different whistles for different patients. Maybe a patient wants a device that isn’t beeping a lot, like the Libre 2. Maybe they want something private that goes directly to their phone, so they pick Dexcom. Maybe they prefer something implantable, so they select Eversense. There is also the Medtronic sensor that is compatible with the Medtronic pump. The Libre is now compatible with smartphones, too. These are all exciting steps allowing us to engage more patients to use this technology. If something does not work for them, now we have the opportunity to offer them two or three other devices.”

Carol J. Levy

Dexcom’s next-generation G7 sensor is also in development. In February, Dexcom and Insulet announced a global commercialization agreement to combine current and future Dexcom CGMs with Insulet’s Omnipod Horizon system for automated insulin delivery, currently in pivotal trials, according to a press release. Under the terms of the nonexclusive agreement, the Omnipod Horizon automated insulin delivery system will use sensor values from the Dexcom G6 and next-generation G7 CGM, once available, to predict glucose levels and automatically adjust the insulin dose required for optimal glucose management.

“The future of CGM — as with many things in technology — is to get smaller and last longer,” Buckingham said. “The G7 will be a much smaller sensor and disposable. There is a new sensor we are just beginning to start clinical studies on that will last 16 days with nonadjunctive use, with a new company. Medtronic getting to nonadjunctive use is also a great plus.”

Future of tech

The latest advancements — along with the pace of change — has researchers excited for what may come next.

Buckingham said technology that can recognize when a person is eating a meal could further alleviate diabetes burden. At Stanford, Buckingham and colleagues are leading a pilot study to examine whether the Klue app is effective in detecting missed or late meal boluses in patients with type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have taken their insulin.

“We’ve done studies with Klue and an Apple Watch worn on the dominant hand, which would recognize eating with about three gestures of moving hand to mouth,” Buckingham said. “It was about 95% accurate, with only two or three false positives per week. It even distinguished drinking from eating or shaving or brushing teeth. We found the hand gestures preceded the rise in glucose by about 12 to 18 minute, so if these hand motions could trigger a pre-meal bolus, even before the glucose rises, then there is a double confirmation of meals, and meal announcements may not be needed. This may get us to full closed loop.”

Levy said people with diabetes can expect devices that do even more to reduce patient burden in the coming years.

“Specifically, customization for specific patient populations,” Levy said. “Older adults, pregnant women — how can we meet these patients where they are and provide them with customized care to meet their glucose targets? One patient may decide they want a 100 mg/dL target instead of 110 or 120 mg/dL. Or a patient may decide they want a target of 140 mg/dL or 150 mg/dL. For pregnancy, the glucose targets are even more stringent. Soon that will be an option. The ability to meet these patients at their clinical status, as well as at their desired glucose target, is important.”

Access for everyone

Laura M. Nally

Talk of a bionic pancreas, a fully closed-loop insulin delivery system and personalized medicine with diabetes devices is exciting; however, such advancements will not be available in the immediate future, Gabbay said.

“Those are long-term goals, and they are wonderful goals,” Gabbay said. “What excites me is increasing access to the devices that already work, particularly with where this country is right now and some of the challenges we have with racial inequities in society. The ADA has taken this on with #HealthEquityNow, where we made a strong commitment to address this issue. Our patient bill of rights includes access to technology. We are in the process of establishing some big partnerships around that.”

Diabetes technology making its way beyond the endocrinologist is also important for increasing access, Gabbay said.

“That is the only way we will reach the number of people who will benefit from it,” Gabbay said. “As endocrinologists, we only see a small percentage of the people with diabetes. If we are the only ones using technology, then that is not the answer. There will be a big learning curve, and the ADA has an initiative around time in range. We must raise awareness among people with diabetes and providers in the primary care setting.”

Insurance plans must also expand access to diabetes technology, Nally said.

“Medicaid programs are different from state to state,” Nally said. “In Connecticut, Omnipods are covered under state health insurance, but they were not covered in California. Here in Connecticut, we have difficulty getting the Freestyle Libre covered, which was a problem I didn’t have when I worked in California. Each state is a little bit different, which makes it harder for the clinician to prescribe the device that will best serve the needs of the patient. It can be frustrating for the patient because it is too expensive to buy these devices out of pocket.”

Cost remains the major barrier preventing access, Shah said.

“On one side, I am excited about next-generation technology, but on the other side, patients are abandoning the technology or not initiating it because they cannot afford it,” Shah said. “You can have a great system, but if the patient cannot afford the technology, it does not matter. Yes, I want to see smaller, smarter devices, but I also want to see affordable devices, too. This is a problem that we are seeing right now. With COVID-19, people have lost jobs and are on Medicaid — Medicaid does not cover CGM. A lot of things are moving in the right direction, but what I want to see are affordable, low-cost devices so everyone can benefit. That is the bottom line.”