Six-months of hybrid closed-loop versus manual insulin delivery with finger-prick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial
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To investigate glycemic and psychosocial outcomes with hybrid closed loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump i.e. standard therapy for most adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS
Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26-weeks HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked-CGM time-in-range (TIR; 70–180mg/dL) during the final 3 weeks.
Participants were randomized to HCL (n=61) or control (n=59). Baseline mean (SD) age 44.2(11.7)years; HbA1c 7.4(0.9)%, 57(10)mmol/mol; 53% were women and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15%; 95% CI 11, 19%; p<0.0001). For HCL, HbA1c was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4mmol/mol [−7, −2]; p<0.0001) and diabetes-specific positive well-being higher (difference 1.2, 95% CI 0.4, 1.9; p<0.0048) without a deterioration in diabetes distress, perceived sleep quality or cognition. Seventeen (nine device-related) vs. thirteen serious adverse events occurred in the HCL and control groups respectively.
In adults with type 1 diabetes 26 weeks of HCL improved TIR, HbA1c and their sense of satisfaction from managing their diabetes than those continuing with user-determined insulin dosing and self-monitoring blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable and advantageous.