Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System
Primary result · Time in hypoglycaemia (54 to <70 mg/dL)Result — go to the resultDifference −4.7 % CI −5.3 to −4.1Authors' 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.
Study context
- Population
- Patients with T1D from three RCTs of DBLG1 whose time below 70 mg/dL during the baseline open-loop phase exceeded 5%
- Participants
- 45 patients
- Comparison
- DBLG1 hybrid closed-loop vs open-loop phase
- Primary endpoint
- Differences between closed-loop and open-loop phases in time in various ranges and Glycemia Risk Index (GRI)
Methodological detailswithin-patient comparison of closed-loop vs open-loop phases
- Within-patient comparison of closed-loop vs open-loop phases
Primary result
Time in hypoglycaemia (54 to <70 mg/dL)
Difference
−4.7 %
CI −5.3 to −4.1
P < 10-4
By group
Closed-loopvs Open-loop
difference −4.7 % (CI −5.3 to −4.1); P < 10-4
As reported in the abstract
Further findings
Time below 54 mg/dL
- Time below 54 mg/dL decreased; difference (P < 10-4)
- −0.9% [−1.4; −0.8]
TIR 70-180 mg/dL
- TIR improved; difference (P < 10-4)
- 5.1% [2.9; 7.0]
Glycemia Risk Index (GRI)
- GRI improved; difference (P < 10-4)
- 13.2 [10.4; 16.0]
Original publication
Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. Published 29 September 2022. doi:10.
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