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OBJECTIVE: We evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: This single-center, randomized, crossover study enrolled 26 adults with type 1 diabetes using insulin pump therapy with suboptimal glycemic control (mean ± SD, age 41 ± 12 years, HbA1c 9.2 ± 1.1% 77 ± 12 mmol/mol). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order. RESULTS: In an intention-to-treat analysis, the proportion of time glucose was in range (primary end point 3.9-10.0 mmol/L) 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, 16.9, P 10.0 mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean ± SD time >10.0 mmol/L: 49.0 ± 9.9 vs. 62.9 ± 12.6%, mean difference -13.3 percentage points 95% CI -17.2, -9.5, P < 0.001; mean ± SD glucose 10.7 ± 1.1 vs. 12.0 ± 1.6 mmol/L, mean difference -1.2 mmol/L 95% CI -1.8, -0.7, P < 0.001). The proportion of time with glucose <3.9 mmol/L was similar between periods (median interquartile range (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 51.9 units/day 35.7-91.2 vs. pump with CGM 50.7 units/day 34.0-70.0, P = 0.704). No severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS: Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.
Boughton et al. (Thu,) studied this question.