Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System - Université Grenoble Alpes
Article Dans Une Revue Journal of diabetes science and technology Année : 2022

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

Alice Adenis
  • Fonction : Auteur
Yousra Tourki
  • Fonction : Auteur
Sylvie Pou
  • Fonction : Auteur
Stéphanie Madrolle
  • Fonction : Auteur
Sylvia Franc
Dulanjalee Kariyawasam
  • Fonction : Auteur
Jacques Beltrand
  • Fonction : Auteur
David Klonoff
Guillaume Charpentier

Résumé

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.

Dates et versions

hal-04559467 , version 1 (25-04-2024)

Identifiants

Citer

Pierre-Yves Benhamou, Alice Adenis, Yousra Tourki, Sylvie Pou, Stéphanie Madrolle, et al.. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. Journal of diabetes science and technology, 2022, 18 (2), pp.372-379. ⟨10.1177/19322968221128565⟩. ⟨hal-04559467⟩

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