Evidence map›Paper›PMID 34009725›Full record

Trial reportDiabetes, obesity & metabolism2021

No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial.

Sylvia Franc, Pierre-Yves Benhamou, Sophie Borot, Lucy Chaillous, Brigitte Delemer, Maeva Doron, Bruno Guerci, Hélène Hanaire, Erik Huneker, Nathalie Jeandidier and 9 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05736263 (Setting a New Algorithm For the Management of Exercise-induced Glycemic Variations in Patients With Type 1 Diabetes in Intensive Therapy With Hybrid Closed-loop Systems), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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.

NCT05736263 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Setting a New Algorithm For the Management of Exercise-induced Glycemic Variations in Patients With Type 1 Diabetes in Intensive Therapy With Hybrid Closed-loop Systems

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2023 to 2024Enrolled50ConditionsType 1 Diabetes, ExerciseArmsModerate intensity exercise, High intensity interval exercise, Combined exercise, Resistance exercise
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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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

19 authors.

Sylvia FrancDepartment of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France.ORCID 0000-0001-5123-7743
Pierre-Yves BenhamouDepartment of Diabetology, University Hospital Grenoble Alpes, Grenoble, France.ORCID 0000-0003-4378-0468
Sophie BorotDepartment of Endocrinology, Metabolism, Diabetes and Nutrition, Centre Hospitalier Universitaire Jean Minjoz, Besançon, France.
Lucy ChaillousCHU de Nantes - Hospital Laennec, Saint-Herblain, France.
Brigitte DelemerDepartment of Endocrinology, Diabetes and Nutrition, Reims University Hospital, Reims, France.
Maeva DoronUniversité Grenoble Alpes, Commissariat à l'Energie Atomique, Laboratoire d'électronique et de technologie de l'information, Département micro Technologies pour la Biologie et la Santé, Grenoble, France.
Bruno GuerciEndocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Lès Nancy, France.
Hélène HanaireDepartment of Diabetology, Metabolic Diseases and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.ORCID 0000-0002-8794-8990
Erik HunekerDiabeloop S.A., Paris, France.
Nathalie JeandidierDepartment of Endocrinology, Diabetes and Nutrition, CHRU of Strasbourg (UDS), Strasbourg, France.
Coralie AmadouDepartment of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France.
Eric RenardDepartment of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, and Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France.ORCID 0000-0002-3407-7263
Yves ReznikDepartment of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center, Caen, France.ORCID 0000-0002-6267-8058
Pauline SchaepelynckDepartment of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.
Chantal SimonDepartment of Endocrinology, Diabetes and Nutrition, Centre Hospitalier Lyon Sud, Lyon, France.
Charles ThivoletCenter for Diabetes, Lyon University Hospital, Lyon, France.
Claire ThomasLaboratoire de Biologie de l'Exercice pour la Performance et la Santé, Université Evry Val d'Essonne, Institut de Recherches Biomédicales des Armées, Université Paris Saclay, Evry, France.
Patrick HannaertSchool of Medicine and Pharmacy of Poitiers, Ischémie Reperfusion en Transplantation d'Organes Mécanismes et Innovations Thérapeutiques, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1082, Poitiers, France.ORCID 0000-0003-4995-3913
Guillaume CharpentierCentre d'Etude et de Recherche pour l'Intensification du Traitement du Diabète (CERITD), Evry, France.

Funding

Diabeloop SAFrench Innovation Fund
6 · The paper itself

Abstract

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system in controlling the hypoglycaemia induced by physical activity (PA) in real-life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P < .0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P < .0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real-life conditions, the use of DBLG1 avoids PA-induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit.

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaBlood GlucoseCross-Over StudiesDietExerciseHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsBlood GlucoseHypoglycemic AgentsInsulinartificial pancreasclosed-loop systemcontinuous glucose monitoringglycaemic controlhypoglycaemiainsulin pump therapyphysical activityphysical interventionrandomized controlled trialtype 1 diabetes

Identifiers

PMID34009725
PMCPMC8453744

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Registered trials

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.