The bionic pancreas improves glycated hemoglobin levels in type 1 diabetics

A bionic pancreas that automatically releases insulin resulted in better control of glycated hemoglobin compared to standard of care in a recent RCT

A bionic pancreas may better control glycated hemoglobin levels compared to standard care, according to a randomized study by a team of US researchers.

The term “diabetes” refers to a group of diseases characterized by high blood sugar levels that occur due to defective production or function of insulin, or both. Type 1 diabetes is the main form, diagnosed in childhood and characterized by elevated blood sugar levels resulting from a lack of insulin. It is relatively common and a 2020 study estimated that the incidence of type 1 diabetes was 15 per 100,000 worldwide and had a prevalence of 9.5%.

Several studies have confirmed that higher glycated hemoglobin (HbA_1c) level is an independent risk factor for diabetes complications. As a result, according to a 2021 consensus report by the American Diabetes Association and the European Association for the Study of Diabetes, an HbA1c was created_1c For most adults, a target of < 53 mmol/mol (< 7.0%) without significant hypoglycemia is appropriate. Still, in a US real-world study of 31,430 type 1 patients, only about 20% had HbA_1c of < 7%.

Currently, hybrid closed-loop insulin delivery systems are able to partially automate insulin delivery and have demonstrated improved glycemic control in adults and adolescents with type 1 diabetes by reducing both hyperglycemia and hypoglycemia. Another innovation is a bionic pancreas, which is an automated insulin delivery system that is initialized using only body weight and no information about previous insulin dosing. A bionic pancreas works in conjunction with a continuous glucose monitoring (CGM) tool to autonomously deliver insulin and/or glucagon to control a person’s blood glucose levels in response to their real-time sensor glucose readings from the CGM.

In the present study, US researchers conducted a randomized trial to compare a bionic pancreas administering either aspart or insulin lispro versus standard of care in terms of glycated hemoglobin control. For the study, any insulin delivery method with unblinded, continuous, real-time glucose monitoring was defined as the standard of care. Subjects aged 6 years and older, diagnosed with type 1 diabetes and using insulin for at least 12 months were randomized 2:1 to bionic pancreas (with insulin aspart or lispro) or usual care. The primary outcome was the glycated hemoglobin level at 13 weeks, while the secondary outcomes were the percentage of time that glucose levels were below 3 mmol/L and the percentage of time that glucose levels were in the target range of 3.9 to 10 mmol/L stayed, included.

Bionic pancreas and glycated hemoglobin

A total of 326 adults and children with an average age of 28 years (49% women in the bionics group) were included in the analysis.

The mean glycated hemoglobin level was 7.3% (vs. a baseline of 7.9%) in the bionic group but remained unchanged at 7.7% in the standard of care group (mean adjusted difference = -0.5, 95% CI – 0.60 to -0.30, p<0.001).

However, the percentage of time with glucose levels below 3 mmol/L was not significantly different. In contrast, both the mean glucose level and the percentage residence time in the target range of 3.9 to 10 mmol/L were statistically significant, which speaks in favor of the bionic pancreas. In fact, using the percentage of time within the target range, the researchers calculated that the 11% difference corresponded to an increase of 2.6 hours/day for the bionic group.

The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic group and 10.8 events in the standard of care group, which was not significant (p = 0.39).

The authors concluded that bionic pancreas was associated with greater reductions in glycated hemoglobin compared to standard care.

Citation
Bionic Pancreas Research Group. Multicenter, randomized study of a bionic pancreas in type 1 diabetes N Eng J Med 2022