Next-generation artificial pancreas ‘user-friendly’ option for teens with type 1 diabetes
Click Here to Manage Email Alerts
Adolescents and young adults with type 1 diabetes who used a next-generation hybrid closed-loop insulin delivery system saw improvements in HbA1c and time-in-range with no increase in hypoglycemia, study data show.
In the FLAIR study, the first randomized, crossover study to a compare a next-generation artificial pancreas, the Medtronic MiniMed 780G, with a commercially approved automated insulin delivery system, participants also reported a greater reduction in daytime hyperglycemia and greater ease of use with the next-generation model, Richard Bergenstal, MD, executive director of the International Diabetes Center Park Nicollet in Minneapolis, said during a presentation at the American Diabetes Association Scientific Sessions. The study design was also unique for its inclusion of participants who were naive to diabetes technology, he said.
“We really wanted to try to move the field forward by asking some tough questions, like who needs this system the most that is not getting enough attention? That is adolescents,” Bergenstal told Healio. “Why is everyone comparing hybrid closed-loop systems in their trials to something that is not state-of-the-art anymore, like an insulin pump? Thirdly, why not broaden these trials? Instead of having everyone come in with good glucose control and expecting minimal improvement, let’s take people who are not using technology right now, perhaps because they are afraid to. That is the beauty of an NIH-funded trial.”
Unique study design
Bergenstal and colleagues analyzed data from 113 adolescents and young adults with type 1 diabetes (aged 14 to 29 years) from seven international diabetes centers, including participants on multiple daily injection therapy (20%), those not using a continuous glucose monitor (38%), and those with an HbA1c between 8.6% and 11% (25%). 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. Participants and their diabetes care partners received standardized pump training, including how to account for meals and exercise. Researchers compared how effective each system was at preventing daytime hyperglycemia and evaluated how participants adjusted to the daily use of the technology.
In assessing time spent in daytime hyperglycemia, researchers found participants’ time spent 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 –3% (P < .001).
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 advanced hybrid closed-loop compared with increasing almost twofold when using the 670G, Bergenstal said.
The mean HbA1c level, which was 7.9% at baseline, fell to 7.4% with advanced hybrid closed-loop compared with 7.6% for the 670G. Mean total daily insulin use was 55 units for the 780G (64% bolus) and 50 units for the 670G (49% bolus). Time spent in automode was 86% and 75%, respectively, for the 780G vs. the 670G.
Researchers did not observe any safety signals with respect to level 3 hypoglycemia or diabetic ketoacidosis, and participant-reported satisfaction was high, Bergenstal said.
“The biggest surprise to me was the important feature of the auto-correction [insulin] bolus,” Bergenstal said. “This is a feature that some other insulin pumps have as well. We tell patients that you have to take your bolus before the meal, even with the latest systems, yet so many don’t. It is good to have that autocorrection feature where it gives you a bolus, and to see that percentage of 36% of the total bolus insulin with the advanced hybrid closed-loop was for correction.”
In a question and answer session after the presentation, Bergenstal noted that it is difficult to compare the findings with data from studies assessing the only other FDA-approved hybrid closed-loop system in the U.S. — the Tandem Control IQ system — due to differences in trial design.
“It is hard to compare, because everyone has slightly different definitions of adolescents and young adults, but I do think that systems that have autocorrection are going to be essential in this tough age group of age 14 years to age 30 years,” Bergenstal said.
Ease of use
In a press release issued Thursday, Medtronic stated that it secured a CE Mark for the 780G in Europe. The system is expected to begin shipping this fall in select European countries, according to the release. In the U.S., the 780G is for investigational use only.
Bergenstal said the FLAIR study shows that individuals using any type of therapy, even multiple daily injections without a pump or CGM system, can benefit from the next-generation hybrid closed-loop therapy.
“If your goal is getting good glucose control without hypoglycemia for people with type 1 diabetes, you really have to consider closed-loop therapy, and you should broaden your horizons with respect to who can benefit,” Bergenstal told Healio. “This does not just have to be so-called ‘super-users.’ Give people a chance. The systems are now so much more user-friendly. With closed-loop insulin delivery, it is all about user-friendliness, effectiveness and safety. The new systems are not perfect yet, but they are getting us toward all three.”
Collapse
Bergenstal R, et al. FLAIR—An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs. 670G. Presented at: American Diabetes Association Scientific Sessions; June 12-16, 2020 (virtual meeting).
Click Here to Manage Email Alerts