Impact of Algorithmic Modifications Targeting the Meal Period and the Management of Hypoglycemia and Hyperglycemia in Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery: A Two-Step Observational Report
Authors' conclusion
This large post-market report illustrates the margin of improvement in AID performances through algorithmic refinements that improve the efficacy without deteriorating the safety of closed-loop insulin delivery.
Study context
- Population
- Consenting adults with T1D equipped in Europe with the DBLG1 hybrid closed-loop system between November 1, 2023 and January 31, 2025
- Exposure
- Successive DBLG1 algorithm versions: v1.12 vs v1.16, then v1.16 vs v1.17
- v1.12n = 269reference
- v1.16n = 668
- Outcome
- TIR 70 to 180 mg/dL
Methodological detailstwo-step analysis, first step retrospective comparison, second step ambispective before/after analysis, post-market
- Two-step analysis
- First step retrospective comparison
- Second step ambispective before/after analysis
- Post-market
Main finding
As reported in the abstract
Median TIR 70–180 mg/dL, first step (v1.12 vs v1.16) · 319 days
v1.12
65.3%
median · IQR 58.4%–72.1%
v1.16
71.3
median · IQR 63.3%–78.0%
Observational data: associations, not effects.
Further findings
| Outcome | v1.16 | v1.17 |
|---|---|---|
| TIR 70–180 mg/dL, second step (ambispective before/after) · 120 days | 68.8% (IQR 59.6%–76.8%) | 70.8% (IQR 63.0%–77.6%) |
- TIR 70–180 mg/dL, second step (ambispective before/after): n = 1212
TIR 70–180 mg/dL, second step (ambispective before/after) · 120 days
- Marginal changes in other glucose metrics
Time in tight range 70–140 mg/dL, first step
- Time in tight range increased
Time in hypoglycemia, first step
- Time in hypoglycemia was stable
Time >250 mg/dL, GMI, CV and GRI, first step
- Time >250 mg/dL, GMI, CV and GRI decreased
Safety
- Time in hypoglycemia was stable (first step)
- Incidence rates of severe hypoglycemia or hyperglycemia remained very low
Original publication
Impact of Algorithmic Modifications Targeting the Meal Period and the Management of Hypoglycemia and Hyperglycemia in Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery: A Two-Step Observational Report. J Diabetes Sci Technol. Published 18 December 2025. doi:10.
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