Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes

Abstract

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closedloop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods:This multi-center, single-arm study involved an intent to treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/-predictive low glucose management or Auto Basal was enabled for ~14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (~90 days), with glucose target set to 100mg/dL or 120mg/dL for ~45 days, followed by the other target for ~45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180mg/dL) and time below range (TBR, <70mg/dL). Run-in and study phase values were compared using Wilcoxon signedrank test a or paired t-test.Results: Overall group time spent in closed loop averaged 94.9±5.4% and involved only 1.2±0.8 exits/week. Compared to run-in, AHCL reduced A1C from 7.5±0.8% to 7.0±0.5% (<0.001 a , N=155), TIR increased from 68.8±10.5% to 74.5±6.9% (<0.001 a ) and TBR reduced from 3.3±2.9% to 2.3±1.7% (<0.001 a ). Similar benefits to glycemia were observed for each age group, and were more pronounced for the nighttime (12AM-6AM). The 100mg/dL target increased TIR to 75.4% (N=155), that was further optimized at a lower active insulin time setting (i.e. 2 hours), without increasing TBR. There were no severe hypoglycemia or diabetic ketoacidosis events during the study phase.Conclusions: These findings show that the MiniMed™ AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D.Adjustments in target and active insulin time settings may further optimize glycemia and improve user experience. a Wilcoxon signed-rank test.

Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real‐world users

“…Both age groups had approximately the same amount of auto correction bolus as a percentage of all boluses (25.0% and 24.6%, respectively). These results are similar to those reported for the system in Collyns et al (25.1%) 26 and Carlson et al (22.0%), 21 yet substantially less than that observed in the FLAIR trial (36%), 25 although a direct comparison between these studies is limited because of differences in participants' ages. The amount of automated bolus, as a percentage of total daily insulin dose, or all boluses administered per day, provide an important and sensitive view for the healthcare provider in that it may highlight behavioural issues that prevent the best glycaemic outcomes.…”

“…The introduction of automated insulin delivery has shifted this paradigm. Clinical pivotal trials of the MiniMed 670G system, 19,20 followed by the MiniMed advanced hybrid closed-loop (AHCL) system, 21 showed that closed-loop control improved HbA1c, TIR and other glycaemic outcomes in youth and adults with T1D. Evidence from large populations of real-world MiniMed 670G 22 and MiniMed 780G system users 23 has also shown improved outcomes, which included a reduction in the glucose management indicator (GMI), a surrogate of HbA1c, and increased TIR, from baseline or before closed-loop initiation.…”

A Response to: Letter to the Editor with Regard to the Cost-Effectiveness of an Advanced Hybrid Closed-Loop System in People with Type 1 Diabetes: A Health Economic Analysis in Sweden

“…Levrat-Guillen and Ghazi suggested that the evidence base for this assumption is lacking. However, Carlson et al [ 14 ] reported no severe hypoglycemic events with AHCL over a 90-day study period, and data from studies on earlier generation devices, including the MiniMed 670G system, are in line with the assumptions applied in the analysis (e.g., Cordero et al [ 8 ] and Petrovski et al [ 15 ]).…”

When Sugar Reaches the Liver: Phenotypes of Patients with Diabetes and NAFLD

“…These patients require close monitoring with dose adjustment for physical activity, illness, or stress. Management of T1DM rapidly changed over recent years, with continuous glucose monitoring, intermittently viewed devices, and closed-loop systems, and an artificial pancreas leading to substantial improvements in glycemic control and quality of life [ 127 , 128 , 129 , 130 ].…”