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Improved Satisfaction While Maintaining Safety and High Time in Range (TIR) with a Medtronic Investigational Enhanced-Advanced Hybrid Closed Loop System (e-AHCL)

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posted on 2024-02-21, 16:38 authored by Cheng Yi Yuan, Yee W. Kong, Tess Amoore, Katrin Brown, Benyamin Grosman, Alicia Jenkins, Hannah JonesHannah Jones, Natalie Kurtz, Melissa H. Lee, Richard MacIsaac, Emma Netzer, Barbora Paldus, Lesley Robinson, Anirban Roy, Catriona M. Sims, Steven Trawley, Sara Vogrin, David N. O’Neal

Objective: To determine feasibility and compare acceptance of an investigational Medtronic enhanced-Advanced Hybrid Closed Loop (e-AHCL) system in type 1 diabetes adults with earlier iterations.

Research Design and Methods: Non-randomised three-stage (each of twelve weeks) exploratory study comparing e-AHCL (Bluetooth®-enabled MiniMed™ 780G insulin pump with automatic data upload [780G] incorporating an updated algorithm; calibration-free all-in-one disposable sensor; seven-day infusion set) preceded by a Run-in (Non-Bluetooth® 780G [670G V4.0 insulin pump] requiring manual data upload; Guardian Sensor 3 [GS3] requiring calibration; three-day infusion set), Stage 1 (780G; GS3; three-day infusion-set) and Stage 2 (780G; calibration-free Guardian Sensor 4; three-day infusion set). Treatment satisfaction was assessed by Diabetes Technology Questionnaire (DTQ)-current (primary outcome) and other validated treatment satisfaction tools with glucose outcomes by continuous glucose monitoring (CGM) metrics.

Results: Twenty-one of 22 (11 women) participants (baseline HbA1c 6.7% / 50mmol/mol) completed the study. DTQ-current scores favored e-AHCL (123.1 [17.8]) vs. Run-in (101.6 [24.2]), and Stage 1 (110.6 [20.8]) (both p<0.001) but did not differ from Stage 2 (119.4 [16.0]; p=0.271). Diabetes Medication System Rating Questionnaire short-form scores for ‘Convenience and Efficacy’ favored e-AHCL over Run-in and all stages. Percent time in range (TIR) 70-180mg/dL was greater with e-AHCL vs. Run-in and Stage 2 (+2.9% and +3.6% respectively; both p<0.001). Percent time <70mg/dL for e-AHCL were significantly lower than Run-in, Stage 1 and Stage 2 ( -0.9%, -0.6%, and -0.5% respectively; all p<0.01).

Conclusions: e-AHCL was feasible. User satisfaction increased compared with earlier Medtronic HCL iterations without compromising glucose control.