Efficacy, Safety, and Satisfaction with the Accu-Chek Insight with Diabeloop Closed-Loop System in Subjects with Type 1 Diabetes: A Multicenter Real-World Study
- 1 April 2023
- journal article
- research article
- Published by Mary Ann Liebert Inc in Diabetes Technology & Therapeutics
- Vol. 25 (4), 242-249
- https://doi.org/10.1089/dia.2022.0449
Abstract
Aim To analyse evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek Insight with Diabeloop™ (DBLG1) in adults with type 1 diabetes (T1D) in real-world conditions. Methods Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analysed at baseline, 1, 2 and 3 months after starting DBLG1. HbA1c was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire. Results Sixty-two patients were included (43 women; age 44.2±11 years; diabetes duration 24.6±12 years; 40 used flash and 22 continuous glucose monitoring; 45 were on insulin pump therapy, 17 on multiple daily injections). A significant improvement was observed in all the CGM-derived glucose metrics eparameters early in the first month: %TIR (55.86±17 vs. 72.23±10.11); %TAR1 (26,26±13.3 vs. 19.48±6.78), %TAR2 (15.02±13.09 vs. 6.14±5.23), %TBR1 (5.73±11.5 vs. 1.67±1,3), %TBR2 (1,18±1.97 vs.0.44±0.49), %CV (38.66±7.53 vs. 29.63±3.74), median glucose (168.57 mg/dl±36 vs. 154.63±17.55), %GMI (7.37±0.91 vs. 7.02±0.42). HbA1c decreased significantly at 3 months (7.45%±1.05 vs. 6.95±0.7). No acute complications or serious adverse events occurred. The sameSimilar improvement was observed regardless of prior therapy or glucose monitoring system used. Three patients stopped discontinued use of using DBLG1 and 21 experienced some technical problemsissues. Overall, patientThe degree of satisfaction was high in most of the questions raised. Adjustments of the settingsThe configuration parameters were modified in general in the direction of greater aggressiveness. Conclusions A significant improvement in glycaemic control without serious adverse events and high degree of patient satisfaction was observed in this first real-world study evaluating the close-loop system Accu-Chek Insight with Diabeloop™Keywords
This publication has 20 references indexed in Scilit:
- Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 DiabetesThe New England Journal of Medicine, 2019
- Efficacy of the Diabeloop closed‐loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exerciseDiabetes, Obesity and Metabolism, 2019
- Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in RangeDiabetes Care, 2019
- Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trialThe Lancet Digital Health, 2019
- Safety Evaluation of the MiniMed 670G System in Children 7–13 Years of Age with Type 1 DiabetesDiabetes Technology & Therapeutics, 2019
- Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trialThe Lancet, 2018
- Glucose Management Indicator (GMI): A New Term for Estimating A1C From Continuous Glucose MonitoringDiabetes Care, 2018
- Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysisBMJ, 2018
- Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop studyActa Diabetologica, 2018
- Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 DiabetesDiabetes Technology & Therapeutics, 2017