First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data
Authors' conclusion
These data obtained in different European countries were consistent throughout all reports, showing that this closed-loop system is efficient (high improvement in TIR), safe (remarkably low level of TBR), and interoperable (three pump settings so far).
Study context
- Population
- Adults with T1D treated with the DBLG1 closed-loop system for 3–12 months, European countries, 2017–20223 RCTs · 5 real-life surveys
- Participants
- 117 / 84 / 6,684
- Comparison
- Closed-loop DBLG1 vs baseline; across three pump systems
- Vicentra Kaleidon = 117
- Sooil Dana-In = 84
- Roche Insightn = 6,684
- Outcome
- TIR 70–180 mg/dL
- Follow-up
- 3 to 12 months
Methodological details3 RCTs and 5 real-life surveys, multinational (European), Data collection March 3, 2017 to April 30, 2022
- 3 RCTs and 5 real-life surveys
- Multinational (European)
- Data collection March 3, 2017 to April 30, 2022
Pooled result
As reported in the abstract
Baseline time in range (TIR)
47.4% to 56.6%
Improvement in TIR
12.2 to 17.3 percentage points
Further pooled results
Time in hypoglycemia
- Average reduction
- 48% (range: 26%-70%)
- Level reached in largest and most recent cohort
- 1.3%
Time below range (TBR) in patients with baseline time in hypoglycemia ≥5%
- Reduction in TBR
- 59%
TBR on days with vs without declared physical activity
- No differences in TBR
Improvement in TIR by pump system
- Range of TIR improvement across three pump systems
- 15.4 to 17.3 percentage points
Original publication
First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data. J Diabetes Sci Technol. Published 14 July 2023. doi:10.
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