Advanced hybrid closed therapy improves blood sugar control in patients with type 1 diabetes: Lancet

Germany: Glycemic control in people with type 1 diabetes is improved by using Medtronic MiniMed 780G system, an advanced hybrid closed therapy (AHCL),finds ADAPT trial.

The findings of the study have been published in The Lancet Diabetes and Endocrinology.

AHCL use confers benefits with regard to glycemic control beyond those that can be achieved with multiple daily injections of insulin plus intermittently scanned continuous glucose monitoring (isCGM). 

An autoimmune illness known as type 1 diabetes (T1D) is defined by the loss of insulin-producing beta cells in the pancreas, which results in insulin insufficiency. Automated insulin delivery for persons with type 1 diabetes has long been a top objective in the field of diabetes technology. It is possible for adults with type 1 diabetes to receive treatment with several daily insulin injections along with intermittently scanned continuous glucose monitoring (isCGM) to have subpar glucose control.

The researchers intended to compare an advanced hybrid closed loop (AHCL) system with this therapy in order to determine which was more effective.

14 centers from three different European nations participated in the Advanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes (ADAPT) experiment, which was prospective, multicenter, open-label, and randomized (France, Germany, and the UK). 105 individuals were tested between July 13, 2020, and March 12, 2021, with 82 being randomly assigned to treatment (41 in each arm).

Using an investigator-blinded block randomization approach, participants were randomly assigned 1:1 to AHCL therapy or to continue receiving multiple daily insulin injections along with continuous glucose monitoring for 6 months. In the intention-to-treat population receiving AHCL therapy and those using multiple daily insulin injections plus isCGM, the primary outcome was the between-group difference in mean HbA1c change from baseline to six months. The number of device flaws, severe hypoglycemic episodes, diabetic ketoacidosis, and major adverse events were considered safety endpoints.

Key findings of the study:

• Patients who were randomly assigned to the closed loop system experienced a 1.54% decline in HbA1c (9% to 7.32%) after 6 months, but those who continued receiving standard treatment only experienced a 0.2% drop (9.07% to 8.91%).
• Compared to only 7% of those receiving numerous daily injections, a total of 52.8% of those using the closed loop were able to consistently attain a time-in-range of more than 70% of the time.
• The closed-loop group's average sensor glucose levels were 152.2 mg/dL compared to 194.7 mg/dL for the group receiving numerous daily injections.
• In addition, compared to people who take numerous daily injections, closed-loop users spent less time with blood glucose levels over 180 mg/dL (26.7 vs 53.8%) and over 250 mg/dL (6.6% vs 22.5%).
• The amount of time each group (2.6% vs. 2.6%) spent in hypoglycemia was the same.
• Only 27.8% of participants in the closed loop system were able to attain an HbA1c below 7% after six months, as opposed to none of the people receiving standard of care.

"The elimination of 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" may be the focus of future developments in closed-loop technology", the researchers wrote.

The authors concluded that the use of AHCL gives benefits for glycaemic control beyond those that can be achieved with multiple daily injections of insulin plus isCGM in persons with type 1 diabetes utilizing multiple daily injections of insulin plus isCGM and with HbA1c of at least 8%.

REFERENCE

Choudhary P, et al "Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): A randomised controlled study" Lancet Diabetes Endocrinol 2022; DOI: 10.1016/ S2213-8587(22)00212-1.