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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Journal of diabetes science and technology - 18(2024), 2 vom: 24. März, Seite 372-379 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Benhamou, Pierre-Yves [VerfasserIn] |
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| Links: |
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| Themen: |
Artificial pancreas |
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| Anmerkungen: |
Date Completed 04.03.2024 Date Revised 30.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1177/19322968221128565 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM346882605 |
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| 100 | 1 | |a Benhamou, Pierre-Yves |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia |b A Post Hoc Analysis of Trials With DBLG1 System |
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| 500 | |a Date Revised 30.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a artificial pancreas | |
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| 700 | 1 | |a Adenis, Alice |e verfasserin |4 aut | |
| 700 | 1 | |a Tourki, Yousra |e verfasserin |4 aut | |
| 700 | 1 | |a Pou, Sylvie |e verfasserin |4 aut | |
| 700 | 1 | |a Madrolle, Stéphanie |e verfasserin |4 aut | |
| 700 | 1 | |a Franc, Sylvia |e verfasserin |4 aut | |
| 700 | 1 | |a Kariyawasam, Dulanjalee |e verfasserin |4 aut | |
| 700 | 1 | |a Beltrand, Jacques |e verfasserin |4 aut | |
| 700 | 1 | |a Klonoff, David C |e verfasserin |4 aut | |
| 700 | 1 | |a Charpentier, Guillaume |e verfasserin |4 aut | |
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