Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial.


Journal

Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R

Informations de publication

Date de publication:
12 06 2021
Historique:
received: 19 02 2021
revised: 19 03 2021
accepted: 29 03 2021
pubmed: 6 6 2021
medline: 13 1 2022
entrez: 5 6 2021
Statut: ppublish

Résumé

People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1). We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36-9·34]; p<0·0001). After 6 months HbA In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. Dexcom.

Sections du résumé

BACKGROUND
People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1).
METHODS
We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA
FINDINGS
Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36-9·34]; p<0·0001). After 6 months HbA
INTERPRETATION
In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes.
FUNDING
Dexcom.

Identifiants

pubmed: 34089660
pii: S0140-6736(21)00789-3
doi: 10.1016/S0140-6736(21)00789-3
pii:
doi:

Substances chimiques

Blood Glucose 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Insulin 0

Banques de données

ClinicalTrials.gov
['NCT03772600']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

2275-2283

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests UZ Leuven received non-financial support for travel from Novo Nordisk for MMV. KU Leuven received non-financial support for travel from Medtronic, and financial support for travel from Roche for SC. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, A Menarini Diagnostics, Eli Lilly, Medtronic, Novo Nordisk, and Roche. RH serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer Ingelheim, and Eli Lilly. LVH reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Merck Sharp and Dohme, Novo Nordisk, and Sanofi-Aventis. GV serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly; reports consulting fees and honoraria for speaking from Merck Sharp and Dohme, Boehringer Ingelheim, AstraZenica, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. ED has served on the advisory panel for Novo Nordisk; ED reports speaking fees from Novo Nordisk, Boehringer-Ingelheim, Eli Lilly, and AstraZenica. NM serves or has served on the advisory panel for Boehringer-Ingelheim; and reports speaking fees from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZenica, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. CV reports consulting and speaking fees from Medtronic, Boehringer Ingelheim, Astra Zeneca, and Sanofi Aventis. FN reports consulting fees and honoraria for speaking from Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Johnson and Johnson, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Roche, and Sanofi-Aventis. CM serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, and Zealand Pharma (financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Roche, Abbott, ActoBio Therapeutics, and Novartis); serves or has served on the speakers' bureau for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Boehringer Ingelheim, AstraZeneca, and Novartis (financial compensation for these activities has been received by KU Leuven). PG serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, and Bayer (financial compensation for these activities has been received by KU Leuven). PG serves or has served on the speakers bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, and Roche (financial compensation for these activities has been received by KU Leuven and KU Leuven received for PG non-financial support for travel from Sanofi-Aventis, A Menarini Diagnostics, Medtronic, and Roche); and received a grant for a senior clinical research fellowship from Fonds Wetenschappelijk Onderzoek Flanders. SC received a doctoral grant for strategic basic research from Fonds Wetenschappelijk Onderzoek Flanders. All disclosures are unrelated to the present work. All other authors declare no competing interests.

Auteurs

Margaretha M Visser (MM)

Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.

Sara Charleer (S)

Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.

Steffen Fieuws (S)

Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven and University of Hasselt, Leuven, Belgium.

Christophe De Block (C)

Department of Endocrinology-Diabetology-Metabolism, University Hospital Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.

Robert Hilbrands (R)

Academic Hospital and Diabetes Research Centre, Vrije Universiteit Brussel, Brussels, Belgium.

Liesbeth Van Huffel (L)

Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium.

Toon Maes (T)

Department of Endocrinology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium.

Gerd Vanhaverbeke (G)

Department of Endocrinology, AZ Groeninge, Kortrijk, Belgium.

Eveline Dirinck (E)

Department of Endocrinology-Diabetology-Metabolism, University Hospital Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.

Nele Myngheer (N)

Department of Endocrinology, AZ Groeninge, Kortrijk, Belgium.

Chris Vercammen (C)

Department of Endocrinology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium.

Frank Nobels (F)

Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium.

Bart Keymeulen (B)

Academic Hospital and Diabetes Research Centre, Vrije Universiteit Brussel, Brussels, Belgium.

Chantal Mathieu (C)

Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium.

Pieter Gillard (P)

Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium; Academic Hospital and Diabetes Research Centre, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: pieter.gillard@uzleuven.be.

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