This week in Paris, companies in the diabetes managment space came together at the Advanced Technologies and Treatments for Diabetes conference to share news and, mostly, a lot of efficacy data. It's an exciting time for the space as closed-loop systems that allow people with diabetes to monitor their glucose continuously and automatically manage their insulin dosing get closer and closer to becoming a validated, regulated reality for people with Type 1 diabetes. We didn't make it out to Paris ourselves, but we're covering the news. We've written up some of the bigger stories from the conference earlier this week. Look below for a roundup of other digital health news from the show.
Nonprofit organization T1D Exchange published a major study in Diabetes Care yesterday (and presented the research at the conference). The data re-affirms the FDA's recent clearance of Dexcom's CGM for insulin dosing. The study looked at 226 adult CGM users for six months. Of those, 149 dosed their insulin using the CGM and 77 used a fingerstick glucometer in addition, as is currently required for most CGMs. There was no difference in outcomes between the two groups.
"This study is an important step to support regulatory pathways for the automation of insulin delivery for people with type 1 diabetes,” Dana Ball, executive director and co-founder of T1D Exchange, said in a statement. “These data are supportive of the recent FDA decision to approve the Dexcom G5 indication for insulin dosing and removes a key obstacle that has prevented reimbursement of CGM by Medicare.”
Integrity Applications, makers of GlucoTrak, a novel non-invasive glucose monitor that clips onto the ear lobe, presented data showing that their device has improved in accuracy from previous generations. The data shows GlucoTrak has increased its tracking consistency, with different devices on opposite earlobes of the same subject returning the same results. They've also corrected for previous inaccuracies in readings before and after meals.
Aspire Ventures announced that its portfolio company Tempo Health's Rhythm system, based on Aspire's A2I adaptive artifical intelligence platform, performed well in an observational study at Diabeter, a specialized treatment center in Europe. Rhythm uses A2I to forecast and manage blood glucose levels of people with diabetes, based on data from non-invasive biometric sensors. In seven out of eight patients in the study, Rhythm would have helped them to achieve a 20 percent increase in time in range, and a 9 percent reduction in low glucose ratings, as compared to the actual results achieved by active monitoring by Diabeter doctors and their diabetes teams using patient-activated remote monitoring.
Waltham, Massachusetts-based Glytec, which makes a personalized therapy and decision support module for patients with diabetes, presented two studies about its Glucommander system. One study saw A1C levels drop from a baseline average of 10.2 percent to 7.7 percent at three months and 7.6 percent at six months. Another study looked at the use of Glucommander for patients prescribed subcutaneous insulin. Among 5,718 patients, the median time to prescribed glucose target was 0.8 days. Once in the target range, 67.9 percent of all blood glucose readings remained between 70 and 180 mg/dL.
Insulet, maker of the Omnipod line of tubeless insulin pumps, presented data about its own closed-loop system, a hybrid system called OmniPod Horizon. The 36-hour, 24-person study used a modified version of Omnipod, a Dexcom CGM sensor, and Insulet’s personalized model predictive control algorithm. Use of the system was associated with significantly less time spent in hypoglycemic blood glucose range compared to ranges prior to the study, the company said. Additionally, patients stayed in the target blood glucose control range 69 percent of the time over the course of the study, including staying in range 90 percent of the time at night.
Valeritas, which makes a wearable, disposable insulin-delivery device called V-Go, shared data showing the device helped lower A1c and insulin dosage better than insulin pens for people with type 2 diabetes. In a retrospective study of 107 people, split roughly in half by use of V-Go versus insulin pens, V-Go users had their A1c levels down by 1.96 percent to insulin pen users’ 1.23 percent reduction. V-Go users also had fewer insulin doses than insulin pen users, with 56 units per day versus 77, respectively, and insulin pen users had to go through 3.6 needle sticks per day while V-Go users only required one.
UK-based device company Nemaura Medical showcased sugarBEAT, its still-in-development continuous glucose-monitoring patch. In a poster session, the company demonstrated the needle-free disposable patch, which is about 1 millimeter thick and uses a small electronic sensor to measure blood sugar levels and streams the data via Bluetooth to a companion smartphone app. They expect to launch at a "cost-competitive" price point next year.