Using a closed-loop system significantly improves time in range (TIR) 70-180 mg/dL in patients with type 1 diabetes (T1D). In a 6-month RCT, 112 subjects were randomly assigned to closed-loop control (Tandem Control-IQ) after obtaining 2 weeks of baseline Continuous glucose monitoring (CGM) data from sensor-augmented pump therapy. We compared glycemic outcomes from baseline to end of study among subgroups classified by baseline HbA1c levels. All HbA1c subgroups showed an improvement in TIR due to reduction of both hyperglycemia and hypoglycemia. Those with HbA1c <6.5% improved mostly by reducing nocturnal hypoglycemia due to the automated basal insulin adjustments. Those with HbA1c ≥8.5% improved mostly by reducing daytime and nocturnal hyperglycemia due to both automated basal insulin adjustments and correction boluses during the day. There does not appear to be any reason to exclude individuals with T1D from automated insulin delivery based on their HbA1c. Clinical Trial Identifier: NCT03563313.
Keywords: Closed-loop system; Continuous glucose monitoring; Glycemic management; International Diabetes Closed-Loop Trial; Time in range; Type 1 diabetes.