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.

Hybrid Closed-Loop Control with Ultrarapid Lispro Compared with Standard Insulin Aspart and Faster Insulin Aspart: An In Silico Study.

OBJECTIVE: There is room for improvement in the performance of closed-loop regulation algorithms during the prandial period. This in silico study evaluated the efficiency and safety of ultrarapid lispro insulin using the Diabeloop DBLG1® algorithm. METHODS: We modeled the insulin profile of URLi according to literature data and integrated it to the model used within a simulation platform built from a 60 patients' virtual cohort. We then ran the DBLG1® algorithm in silico with various meal intakes using modeled URLi, Aspart and Faster Aspart. The primary endpoints were glucose metrics (time in 70-180 mg/dL range and time below range). RESULTS: When insulin time constant values were tuned, time in 70-180 mg/dL range was 69.4 [61.1-75.6] (Aspart) vs 74.7 [65.5-81.5] (URLi). Glucose coefficient of variation was reduced from 34.1 [29.7-37.8] to 28.4 [25.7-34.6]. Time below 70 mg/dL and 54 mg/dL were significantly reduced with URLi, whether or not DBLG1 was specifically tuned to this insulin. Metrics with Faster Aspart were intermediate and did not significantly differ from URLi. CONCLUSIONS: This simulation study performed on a virtual T1D population suggests that the use of URLi within an unmodified closed-loop DBLG1 regulation algorithm is safe and, with DBLG1 being tuned to this specific insulin type, improved the regulation performances as compared with Aspart. This fact supports the use of such an insulin in clinical investigations.

Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System.

BACKGROUND: Automated insulin delivery is an efficient treatment for patients with type 1 diabetes. Little is known on its impact on patients with excessive time in hypoglycaemia. METHODS: We performed a post hoc analysis of three randomized control trials that used the DBLG1 (Diabeloop Generation 1) hybrid closed-loop solution. Patients whose time below 70 mg/dL during baseline, open-loop phase exceeded 5% were selected. The outcomes were the differences between the closed-loop and the open-loop phases in time in various ranges and Glycemia Risk Index (GRI). RESULTS: We identified 45 patients exhibiting ≥5% of time below 70 mg/dL during the open-loop phase. Under closed-loop, the time in hypoglycaemia (54 to <70 mg/dL) dropped from 7.9% (SD 2.4) to 3.2% (SD 1.6) (difference -4.7% [-5.3; -4.1], P < 10-4). The time below 54 mg/dL decreased from 1.9% (SD 1.3) to 0.8% (SD 0.7) (difference -0.9% [-1.4; -0.8], P < 10-4). The time in range (TIR 70-180 mg/dL) improved from 63.3 (SD 9.5) to 68.2% (SD 8.2) (difference 5.1% [2.9; 7.0], P < 10-4). The GRI improved from 51.2 (SD 12.4) to 38.0 (SD 10.9) (difference 13.2 [10.4; 16.0], P < 10-4). CONCLUSION: DBLG1 decreased time in hypoglycaemia by more than 50% even in patients with excessive time in hypoglycaemia at baseline, while also improving both TIR and GRI, under real-life conditions. The improvement in GRI (13.2%) exceeded that of the improvement in TIR (5.1%) indicating that in this data set, GRI was more sensitive than TIR to the improvement in glycaemia achieved with closed-loop. These results support the safety and efficacy of this treatment.