Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes

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.

Real-World Performance of the MiniMed™ 780G System: First Report of Outcomes from 4120 Users

“…A relatively lower rate of mean targets achieved, as well as the proportion attaining goals, have been reported in two RCTs of 3 to 6-months duration 21,22 . However, a shorter RCT investigating the same AHCL system used in the FLAIR trial, demonstrated greatest improvement in the TIR (+14.4%) for adolescents 12 . Whether these results stem from differences in algorithms 22 , suboptimal settings and reduced meal bolusing 21 or more optimized settings in a well-controlled group 12 , the specific challenges in managing diabetes in youth will be assessed in future cohorts.…”

“…When using the optimal system settings of a 100 mg/dL glucose target and active insulin time (AIT) of 2 hours, users achieved an increased TIR of 78.8±5.5%. In a separate AHCL system randomized controlled trial in children, adolescents and adults, 12 the proportion of users achieving TIR >70% increased from 12% at baseline to 51% during AHCL use. The MiniMed™ 780G system received Conformité Europëenne (CE) Mark in June 2020, and is indicated for people with T1DM aged 7-80 years old, whose total daily dose of insulin is 8 units per day or more.…”

The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System in People with Type 1 Diabetes: a Health Economic Analysis in Sweden

“…Treatment effects for the MiniMed 780G system and isCGM plus MDI or CSII were sourced from a recent randomized crossover trial and the FUTURE study, respectively (Table 1) [17,23]. In the MiniMed 780G arm, HbA1c was reduced by 0.5%, and the rate of severe hypoglycemic events (requiring the assistance of a third party) was set to zero, in line with the results from the randomized trial [17].…”

“…The MiniMed 780G represents an AHCL system that automatically adjusts basal insulin delivery, as well as providing safe correction bolus doses as required, via an algorithm that updates insulin delivery every 5 min. This system was evaluated versus SAP therapy with PLGM in a recent study [17].…”

“…That randomized, open-label, crossover study, performed at two centers and conducted in automated-insulin-delivery-naïve participants with type 1 diabetes (aged between 7-80 years; n = 60), found that time in range (TIR) was improved with AHCL versus SAP plus PLGM, with higher use of the automated mode and no increase in hypoglycemia [17]. The automated features of AHCL systems could also relieve the burden of insulin administration from people with type 1 diabetes, thereby offering quality-of-life benefits and reduced fear of hypoglycemia [18].…”