Fully closed-loop glucose control compared to insulin pump therapy with continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glycemic control: a single-centre, randomized, crossover study
Year: 2023
Type: other
Abstract: Objective We evaluated the safety and efficacy of fully closed-loop with ultra-rapid insulin Lispro in adults with type 1 diabetes and sub-optimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). Research Design and Methods In a single-centre, randomized, crossover study, 26 adults with type 1 diabetes using insulin pump therapy with sub-optimal glycemic control (mean±SD, age 41±12 years, HbA1c 9.2±1.1%[77±12mmol/mol]) underwent two 8-week periods of unrestricted living comparing fully closed-loop with ultra-rapid insulin Lispro to insulin pump therapy with CGM in random order. Trial registration:NCT04977908. Results In an intention-to-treat analysis, the proportion of time glucose was in range (3.9 to 10.0mmol/L; primary endpoint) was higher during closed-loop than during pump with CGM (mean±SD 50.0±9.6% vs. 36.2±12.2%; mean difference 13.2 percentage points [95%CI 9.5 to 16.9]; P<0.001). Time with glucose above >10.0mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean±SD time >10.0mmol/L: 49.0±9.9% vs. 62.9±12.6%; mean difference -13.3 percentage points [95%CI -17.2 to -9.5], P<0.001; mean glucose 10.7±1.1mmol/L vs 12.0±1.6mmol/L; mean difference -1.2mmol/L [95%CI -1.8 to -0.7], P<0.001). The proportion of time with glucose <3.9mmol/L was similar between periods (median[IQR] closed-loop 0.88% [0.51-1.55] vs. pump with CGM 0.64% [0.28-1.10]; P=0.102). Total daily insulin requirements did not differ (median[IQR] closed-loop 51.9units/day [35.7-91.2] vs. pump with CGM 50.7units/day [34.0-70.0]; P=0.704). No severe hypoglycaemia or ketoacidosis occurred. Conclusions Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared to insulin pump therapy with CGM in adults with type 1 diabetes and sub-optimal glycemic control.
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4386119424