Insulin Requirements According to Sex and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery.

BACKGROUND: The prediction of the individual insulin needs may facilitate the initiation of insulin therapy. Our aim was to explore the relationships between body weight, sex, and daily amounts of insulin delivered by a hybrid closed-loop system. METHODS: We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Europe with the Diabeloop Generation 1 (DBLG1) hybrid closed-loop insulin delivery device between March 1, 2021 and February 28, 2023. RESULTS: A total of 9036 users (59% females, age 45.6 ± 14.3 years) were included, reaching a mean follow-up of 320 ± 143 days, an overall 2 887 188 days of data. We observed a mean insulin-weight ratio of 0.617 ± 0.207 U/kg (0.665 ± 0.217 for males and 0.584 ± 0.193 for females, P < .001). Exploratory analysis of a subset of 4066 patients reaching >70% Time in Range (70-180 mg/dL) showed a mean insulin-weight ratio of 0.55 ± 0.17 U/kg (P < .001) (0.59 ± 0.18 for the 1438 males and 0.53 ± 0.16 for the 2628 females). CONCLUSION: This large real-world analysis provides a quantitative estimation of the daily insulin requirements in adult patients with type 1 diabetes and shows significant differences between sex. These findings have relevant implications in the practical management of insulin therapy.

One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany.

AIM: The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting. METHODS: We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage. RESULTS: In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%). CONCLUSION: This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.