Abstract
OBJECTIVE To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery-naive participants with type 1 diabetes (aged 7-80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout. RESULTS The study was completed by 59 of 60 people (mean age 23.3 +/- 14.4 years). Time in target range (TIR) 3.9-10 mmol/L (70-180 mg/dL) favored AHCL over SAP + PLGM (70.4 +/- 8.1% vs. 57.9 +/- 11.7%) by 12.5 +/- 8.5% (P < 0.001), with greater improvement overnight (18.8 +/- 12.9%, P < 0.001). All age-groups (children [7-13 years], adolescents [14-21 years], and adults [>22 years]) demonstrated improvement, with adolescents showing the largest improvement (14.4 +/- 8.4%). Mean sensor glucose (SG) at run-in was 9.3 +/- 0.9 mmol/L (167 +/- 16.2 mg/dL) and improved with AHCL (8.5 +/- 0.7 mmol/L [153 +/- 12.6 mg/dL], P < 0.001), but deteriorated during PLGM (9.5 +/- 1.1 mmol/L [17 +/- 19.8 mg/dL], P < 0.001). TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared with 6.7 mmol/L (120 mg/dL), 72.0 +/- 7.9% vs. 64.6 +/- 6.9%, respectively, with no additional hypoglycemia. Auto Mode was active 96.4 +/- 4.0% of the time. The percentage of hypoglycemia at baseline (<3.9 mmol/L [70 mg/dL] and <= 3.0 mmol/L [54 mg/dL]) was 3.1 +/- 2.1% and 0.5 +/- 0.6%, respectively. During AHCL, the percentage time at <3.9 mmol/L (70 mg/dL) improved to 2.1 +/- 1.4% (P = 0.034) and was statistically but not clinically reduced for <= 3.0 mmol/L (54 mg/dL) (0.5 +/- 0.5%; P = 0.025). There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP + PLGM arm. CONCLUSIONS AHCL with automated correction bolus demonstrated significant improvement in glucose control compared with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.