The beneficial effects of closed‐loop insulin delivery in patients with highly unstable type 1 diabetes eligible for islet transplantation are maintained over 6 months: An extension study of the DBLHU‐WP10 trial

Benhamou, Pierre Yves; Lablanche, Sandrine; Vambergue, A.; Pou, Sylvie; Madrolle, Stéphanie; Ugalde, Hector M. Romero; Franc, Sylvia; Charpentier, G.

doi:10.1111/dom.14654

Cited by 5 publications

(6 citation statements)

References 19 publications

(24 reference statements)

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“…Actually, very positive outcomes have been recently reported with a specifically designed and customizable closed-loop solution in patients presenting with hypoglycaemia unawareness and a history of severe hypoglycemic episodes. 18,19 In conclusion, our study supports the use of closed-loop treatment also in T1D patients experiencing excessive time in hypoglycaemia and brings arguments for the efficacy and safety of this treatment in this population.…”

Section: Discussionsupporting

confidence: 69%

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

Benhamou

Adenis²,

Tourki³

et al. 2022

J Diabetes Sci Technol

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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.

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Section: Discussionsupporting

confidence: 69%

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

Benhamou

Adenis²,

Tourki³

et al. 2022

J Diabetes Sci Technol

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“…Finally, a dedicated version of the controller, called DBLhu, was developed for the specific needs of patients with a history of hypoglycemia unawareness and grade 3, severe hypoglycemia, validated in a RCT and used in routine care for this population. 27,28 In conclusion, we have collected a large amount of clinical data, both in RCTs and real-life, obtained in different European countries and various pump setting, that were consistent throughout all reports. Overall data show that the first generation of this French closed-loop system is efficient (high improvement in TIR), safe (remarkably low level of TBR), and interoperable, allowing half of the users to achieve the international CGM standards.…”

Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 99%

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

Benhamou

Adenis²,

Lablanche

et al. 2023

J Diabetes Sci Technol

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Background: DBLG1 (Diabeloop Generation 1) stands as one of the five commercially available closed-loop solution worldwide for patients with type 1 diabetes as of 2023. Our aim was to provide an overview of all data obtained with this system regarding outcomes and populations, with an emphasis on interoperability. Methods: This report includes all available sources of data (three randomized control trials and five surveys on real-life data). Collection ran from March 3, 2017 to April 30, 2022. Results: We gathered data from 6859 adult patients treated with closed-loop from three to 12 months. Overall, all sources of data showed that time in range (TIR) 70 to 180 mg/dL, starting from 47.4% to 56.6%, improved from 12.2 to 17.3 percentage points. Time in hypoglycemia was reduced by 48% in average (range: 26%-70%) and reached a level of 1.3% in the largest and most recent cohort. In patients with excessive time in hypoglycemia at baseline (≥5%), closed-loop allowed a reduction in time below range (TBR) by 59%. The comparison of days with declared physical activity versus days without physical activity did not show differences in TBR. The improvement in TIR observed with three different pump systems (Vicentra Kaleido, n = 117; Sooil Dana-I, n = 84; and Roche Insight, n = 6684) ranged from 15.4 to 17.3 percentage points. Discussion: 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).

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“…37 However, the need for transplantation may decline as automated insulin delivery systems improve over time. 38 As with baseline HU, follow-up measures of glucose control were 18 However, the widespread feasibility and long-term effectiveness of such programs is unknown.…”

Section: Discussionmentioning

confidence: 99%

“…Traditionally beta cell replacement strategies including islet transplantation or pancreas transplants have been considered the gold standard method for patients with severe refractory hypoglycemia 37 . However, the need for transplantation may decline as automated insulin delivery systems improve over time 38 …”

Section: Discussionmentioning

confidence: 99%

Predictors of change in hypoglycemia unawareness among patients with type 1 diabetes

Melnychuk

Wyne

Dungan

2022

Diabetes Metabolism Res

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Aims To analyse predictors of hypoglycemia unawareness (HU) and improvement in Clarke score in clinical practice. Materials and Methods We retrospectively identified patients with type 1 diabetes (T1D) at an academic T1D clinic who completed HU surveys 6–12 months apart. HU (Clarke score ≥4) and improvement in Clarke score (decrease by ≥1 point or more clinically relevant ≥2 point) were assessed in univariable relationships and using multivariable logistic regression. Results Of the 300 participants, median diabetes duration was 19 years, 47 had HU at baseline, and 91 had an improvement by 1 point while 21 had an improvement by 2 points. Patients with baseline Clarke score ≥4 who had ≥1 or ≥2 point improvement had lower filtration rate (eGFR) than those who did not. After adjustment for other variables, gender (male OR 0.33, 95% CI 0.15, 0.74), log diabetes duration (OR 6.40, 95% CI 2.84, 14.5), and eGFR <60 ml/min/1.73 m2 (5.56, 95% CI 1.98, 15.6) were independent predictors of baseline HU. Continuous glucose monitoring use (OR 2.04, 95% CI 1.20, 3.48) and log diabetes duration (OR 1.78, 95% CI 1.22, 2.60) were independent predictors of 1 point improvement and eGFR <60 ml/min/1.73 m2 (OR 10.5, 95% CI 3.64, 30.0) and an education visit (OR 2.64, 95% CI 1.01, 6.89) were independent predictors of 2 point improvement in Clarke score. Conclusions Diabetes duration, gender, and eGFR were independent predictors of HU. Improvement in Clarke score is possible in patients with long‐standing T1D, underscoring the need for additional study.

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The beneficial effects of closed‐loop insulin delivery in patients with highly unstable type 1 diabetes eligible for islet transplantation are maintained over 6 months: An extension study of the DBLHU‐WP10 trial

Cited by 5 publications

References 19 publications

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

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

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

Predictors of change in hypoglycemia unawareness among patients with type 1 diabetes

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