Evidence map›Paper›PMID 37449762›Full record

ArticleJournal of diabetes science and technology2023

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.

Pierre-Yves Benhamou, Alice Adenis, Sandrine Lablanche, Sylvia Franc, Coralie Amadou, Alfred Penfornis, Dulanjalee Kariyawasam, Jacques Beltrand, Guillaume Charpentier

Abstract read
In one paragraph

Article in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Pierre-Yves BenhamouDepartment of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, Laboratory of Fundamental and Applied Bioenergetics, Grenoble, France.ORCID 0000-0003-4378-0468
Alice AdenisDiabeloop SA, Paris, France.
Sandrine LablancheDepartment of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, Laboratory of Fundamental and Applied Bioenergetics, Grenoble, France.
Sylvia FrancCenter for Study and Research for Improvement of the Treatment of Diabetes, Bioparc-Genopole Evry-Corbeil, Evry, France.
Coralie AmadouDepartment of Endocrinology, Diabetology & Metabolic Diseases, Sud-Francilien Hospital, Paris-Saclay University, Corbeil-Essonnes, France.
Alfred PenfornisDepartment of Endocrinology, Diabetology & Metabolic Diseases, Sud-Francilien Hospital, Paris-Saclay University, Corbeil-Essonnes, France.ORCID 0000-0002-9635-7674
Dulanjalee KariyawasamPaediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France.
Jacques BeltrandPaediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France.
Guillaume CharpentierCenter for Study and Research for Improvement of the Treatment of Diabetes, Bioparc-Genopole Evry-Corbeil, Evry, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDBLG1 (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.

methodsThis 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.

resultsWe 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).

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaAdultBlood GlucoseHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsInsulin, Regular, HumanBlood GlucoseHypoglycemic AgentsInsulinInsulin, Regular, Humanartificial pancreasautomated insulin deliveryclosed-looptype 1 diabetes

Identifiers

PMID37449762
PMCPMC10658690

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.