A new version of Medtronic’s advanced, hybrid closed-loop insulin delivery system showed it could help improve blood sugar control throughout the day in adolescents and young adults with Type 1 diabetes.
The clinical study compared the next-generation system to the medtech giant’s mainstay connected insulin pump, the MiniMed 670G, designed to adjust background insulin levels every five minutes based on readings from a continuous glucose monitor.
In this trial, the newer system employed the same 670G hardware but incorporated an upgraded “fuzzy logic” algorithm aimed at reducing the number of high blood sugar events while also avoiding drops to low blood sugar levels.
Among participants aged 14 to 29, the system increased the amount of time spent in a healthy glucose range by 10 percentage points, up to about 16 hours across a 24-hour period.
At the same time, the advanced system had a larger number of individuals reaching a time-in-range target of 70%, up threefold compared to baseline, versus the previous 670G’s twofold increase.
Sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, the study and its results were presented virtually at the annual scientific sessions of the American Diabetes Association (ADA).
“This age group has traditionally been the most difficult group in which to optimize glucose management and the FLAIR study shows that individuals using any type of therapy, even insulin injections without a pump or CGM system, can benefit from the next generation [advanced, hybrid closed loop automated insulin delivery] therapy,” said the study’s co-primary investigator, Richard Bergenstal, executive director of the International Diabetes Center at HealthPartners.
“There is much interest in the future of advanced technology to treat Type 1 diabetes and the AHCL system is a significant step forward for adolescents or young adults who have a hard time managing their glucose levels,” added Bergenstal, who previously served as the ADA’s president of medicine and science.
At the same time, Medtronic this week received a CE mark approval for the newest model of its advanced hybrid closed loop system in Type 1 diabetes—dubbed the MiniMed 780G—which includes upgraded algorithms as well as the ability to deliver automatic boluses of insulin while also maintaining background levels of the drug.
“We know it can be challenging to have to calculate carbohydrate intake before every snack or meal on a daily basis to ensure the right amount of insulin is dosed,” said Sean Salmon, president of the Medtronic’s diabetes group.
“With this system, users will have an extra layer of coverage for those times they miscalculate their carbs or forget to pre-bolus with an algorithm that automatically corrects for high glucose when needed,” Salmon said.
The 780G is built on technology acquired from DreaMed Diabetes in 2015 and features Bluetooth to connect it with a smartphone app. The system is expected to begin shipping this fall in select European countries, according to Medtronic—which also presented new data from a U.S. pivotal trial of the 780G system at the ADA meeting.
The 90-day, home-based study, which included participants aged 14 to 75 years old, showed no instances of severe hypoglycemia or diabetic ketoacidosis, as well as an average A1C of 7.0%.
Overall, participants spent three-quarters of their time within a healthy blood sugar range, defined as between 70 mg/dL and 180 mg/dL, with 1.8% of time being spent below those guardrails. Overnight readings showed participants spent 82% of those hours within the range.
Additionally, the 780G’s automatic insulin corrections accounted for about one-fifth of all boluses delivered during the study.
Meanwhile, a separate clinical trial conducted in New Zealand included participants as young as seven years old and showed a 13 percentage-point overall improvement in time spent in range.
“We wanted to design a system that further simplifies diabetes management and provides an extra layer of protection for the times one may forget a pre-meal bolus or miscalculate their carbohydrates,” said Robert Vigersky, chief medical officer of Medtronic’s diabetes group.
“The combination of these two study findings, across a broad spectrum of patients at various levels of glucose control, are promising—they demonstrate that the smart automation featured in this next-generation system has tremendous potential for meaningfully reducing burden and enhancing quality of life,” Vigersky said.
Alongside the ADA meeting, Medtronic’s diabetes group announced a multiyear investment agreement from Blackstone Life Sciences, which could dump up to $337 million into four undisclosed diabetes projects.
This represents the first investment in the medical devices space by Blackstone’s multibillion-dollar fund, which was first publicized in early January.