Impact of Simplera Sync™ sensors and Extended™ Wear Infusion Sets on glycaemia and system performance of the MiniMed™ 780G system in children and young adults with previously high HbA1c

Abstract

Aims: The MiniMed™ 780G improves glycaemia and reduces burden in type 1 diabetes. We investigated how new all-in-one "Simplera Sync™" sensors and 7-day Extended™ Wear Infusion Sets (EIS) affect glycaemia and system performance in young people with previously elevated HbA1c levels (≥69 mmol/mol [≥8%]) after transitioning from 780G with Guardian 4™ sensors and 3-day infusion sets.

Methods: We conducted an extension phase analysis in 75 participants (aged 7-25 years) initially enrolled in the CO-PILOT randomised controlled trial. For this analysis, baseline was defined as the period following the use of 780G with Guardian 4™ sensors and 3-day infusion sets. Participants then transitioned to 780G with Simplera Sync™ and EIS. We compared glycaemic and system performance outcomes from baseline to those after the transition to 780G with Simplera Sync™ and EIS.

Results: Baseline HbA1c was 66.1 mmol/mol ± 14.2 mmol/mol and remained stable at 66.7 mmol/mol ± 11.2 mmol/mol after the transition (p = 0.38). Time in range (3.9-10.0 mmol/L [70-180 mg/dL]) at baseline was 58.5% ± 14.9% and 60.4% ± 15.7% after transition (p = 0.09). Time in tight range (3.9-7.8 mmol/L [70-140 mg/dL]) increased from 38.1% ± 13.1% at baseline to 40.5% ± 13.6% after the transition (p = 0.04). While using 780G with Simplera Sync™ and EIS, automation time increased from baseline 79.2% ± 25.9% to 85.8% ± 21.8% (p = 0.007), and sensor wear time from 80.7% ± 22.4% at baseline to 88.4% ± 17.2% (p < 0001).

Conclusions: Simplera Sync™ and EIS improved time in automation and sensor wear time when using 780G AHCL in this high-risk young population. This was associated with incremental improvement in time in tight range despite the challenges of this population.

Keywords: advanced hybrid closed loop; artificial pancreas; glycaemia; system performance; type 1 diabetes; youth.

FIGURE 1

HbA1c at baseline and study end. (a) displays each individual shown in black, with the mean and standard deviation displayed in red. (b) shows means for the following groups: green (dash line) represents each participant who had time in automation ≥80% at both baseline and study end (n = 38), blue (dot line) represents those with automation time ≥80% at baseline but not at study end (n = 5), pink (dash‐dot‐dash line) represents participants who had automation time ≥80% at study end but not at baseline (n = 13), and black (dash‐dot‐dot‐dash line) represents those who did not have automation time ≥80% at either timepoint (n = 11), mean and standard deviation for the entire cohort (n = 67) is shown in red (solid line). The figure illustrates group means without measures of variability.

FIGURE 2

Glycaemic outcomes for participants at baseline and study end. ^a p value = 0.04 for change in time in the glycaemic range of 10.0–13.9 mmol/L; ^b p value = 0.04 for change in time in the glycaemic range of 3.9–7.8 mmol/L; No other TIR changes were statistically significant. The figure illustrates group means without measures of variability. Additionally, the variables for time in glycaemic ranges are mixed; some are normally distributed while others have skewed distribution. For these reasons, this figure is for illustrative purposes only.