乌鸦传媒

The Medtronic MiniMed 780G system, an advanced hybrid closed therapy (AHCL), improved glycemic control in adults with type 1 diabetes, the ADAPT trial found.

After 6 months, patients randomized to the closed loop system saw a 1.54% drop in HbA1c (9% to 7.32%), while those who remained on standard of care had only a 0.2% drop in A1c (9.07% to 8.91%), reported Pratik Choudhary, MBBS, of King's College Hospital NHS Foundation Trust in London, and colleagues.

As noted in their study in , standard of care involved multiple daily injections of insulin plus intermittently scanned continuous glucose monitoring.

Patients using the closed loop system also spent significantly more time within target range -- between 70 and 180 mg/dL (70.6% vs 43.6%). A total of 52.8% of those using the closed loop were able to achieve a time-in-range more than 70% of the time versus only 7% of those on multiple daily injections.

Average sensor glucose levels were 152.2 mg/dL for the closed loop group versus 194.7 mg/dL for those on multiple daily injections.

Closed loop users also spent less time with glucose levels over 180 mg/dL (26.7% vs 53.8%) or with levels over 250 mg/dL (6.6% vs 22.5%) compared with those on multiple daily injections.

However, there was no difference in the time spent in hypoglycemia between the two groups (2.6% vs 2.6%).

While no participants on standard of care were able to achieve an HbA1c below 7% after 6 months, 27.8% of those on the closed loop system did.

Writing in an , Peter G. Jacobs, PhD, of Oregon Health and Science University in Portland, pointed out that "[a]lthough the results by Choudhary and colleagues are significant, most participants using AHCL were still unable to achieve the consensus guideline target goal of an HbA1c of less than 7.0%, with only 27.8% achieving this goal in the AHCL group."

He added that "this low percentage of people achieving the target HbA1c highlights shortcomings of closed-loop technologies and the need for improvements."

"Choudhary and colleagues also theorize that a possible reason for this could be that a population with higher HbA1c might have a higher likelihood of missed or late boluses, more errors with carbohydrate counting, and a greater fear of hypoglycemia leading to increased intake of unnecessary carbohydrates," Jacobs noted.

He suggested that because of this, future advances in closed loop technology might focus on eradicating the need for "entry of carbohydrates, integration of additional hormones including co-formulation of insulin with pramlintide, and more personalized and adaptive systems that can respond automatically to exercise and other life events."

That being said, the closed loop system was also safe, with no reports of diabetes ketoacidosis, severe hypoglycemia, or serious adverse events related to the device during the trial.

Beyond glucose improvements, closed loop users also reported higher treatment satisfaction after 6 months of treatment, scoring significantly higher on the Diabetes Treatment Satisfaction Questionnaire. Both groups also reported less fear of hypoglycemia by the end of the trial, although closed loop users saw a larger drop in Hypoglycemia Fear Survey total score.

"The MiniMed 780G system is now available in over 60 countries around the world and is currently being reviewed by the [FDA] for approval in the U.S.," Medtronic noted in a .

Participants using the closed loop system in the trial used the already available MiniMed 670G fitted with the new MiniMed 780G algorithm.

"The MiniMed 780G advanced hybrid closed loop system is the latest generation automated insulin delivery system for use in people living with type 1 diabetes and incorporates several advanced features, such as auto basal and auto corrections," Choudhary and co-authors explained.

The trial included 82 adults with type 1 diabetes across 14 centers in France, Germany, and the U.K. -- 41 participants randomly assigned to each arm. All participants had to have type 1 diabetes for at least 2 years prior to baseline and have an HbA1c of at least 8%. Some exclusion criteria included use of pramlintide, DPP-4 inhibitors, GLP-1 receptor agonists, metformin, or SGLT2 inhibitors.

Comment