RESUMO
Background The advanced hybrid closed loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal performance, which poses a challenge for some. We aimed to compare glucose control in adults with T1D using the MiniMedTM 780G AHCL system utilizing simplified meal announcement versus precise carbohydrate counting. Methods In a study involving 14 adults with T1D, we evaluated glycemic control during a 13 week "precise phase", followed by two 3-4 week simplified meal announcement phases: "universal" (preset of one personalized fixed carbohydrate amount) and "incremental" (entry of multiples of one, two, or three of these presets depending on meal size estimate). Results Mean age was 45.7±12.4 and ten participants were male (71%). Mean baseline HbA1c was 6.8%±1.2% and TIR 67.5%±16.7%. Comparing the universal to the precise study phase, TIR was similar (75.4±13% vs. 77.7±9%, p=0.12) and GMI was slightly higher (6.8±0.4 vs. 6.6±0, p=0.01). Furthermore, there was less level 1 and 2 hypoglycemia (1.6±1% vs. 2.8±2%, p=0.03 and 0.3±5% vs. 0.65±1%, p=0.08), but slightly more level 1 and 2 hyperglycemia (17.1±8% vs. 15.0±7%, p=0.05 and 5.5±5% vs. 3.6±3%, p=0.04). When comparing the incremental to the precise phase, GMI was identical (6.6%) and TIR superior (80.5±10% vs. 77.7±9%, p=0.02). Additionally, there was less level 1 hypoglycemia (1.9±1% vs. 2.8±2%, p=0.01) and a trend for less level 2 hypoglycemia (0.4±0.7% vs. 0.65±1%, p=0.08). Conclusions A simplified meal announcement strategy in adults using the MiniMedTM780G system, relying on three increments of a universal CHO amount, may offer a way to improve glycemic control and ease self-care. For patients with more limitations, using one universal CHO amount could be a safe alternative meeting most consensus glycemic targets.
RESUMO
OBJECTIVE: To determine feasibility and compare acceptance of an investigational Medtronic enhanced advanced hybrid closed-loop (e-AHCL) system in adults with type 1 diabetes with earlier iterations. RESEARCH DESIGN AND METHODS: This nonrandomized three-stage (12 weeks each) exploratory study compared e-AHCL (Bluetooth-enabled MiniMed 780G insulin pump with automatic data upload [780G] incorporating an updated algorithm; calibration-free all-in-one disposable sensor; 7-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; 3-day infusion set), stage 1 (780G; GS3; 3-day infusion set), and stage 2 (780G; calibration-free Guardian Sensor 4; 3-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 metrics. RESULTS: Twenty-one of 22 (11 women) participants (baseline HbA1c 6.7%/50 mmol/mol) completed the study. DTQ-current scores favored e-AHCL (123.1 [17.8]) versus run-in (101.6 [24.2]) and versus 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 70-180 mg/dL was greater with e-AHCL versus run-in and stage 2 (+2.9% and +3.6%, respectively; both P < 0.001). Percent times of <70 mg/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.