Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial.
Adult
Belgium
Blood Glucose
/ analysis
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1
/ drug therapy
Female
Glycated Hemoglobin
/ analysis
Humans
Hypoglycemia
/ diagnosis
Hypoglycemic Agents
/ therapeutic use
Insulin
/ therapeutic use
Insulin Infusion Systems
Male
Prospective Studies
Quality of Life
Journal
Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R
Informations de publication
Date de publication:
12 06 2021
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
2275-2283Commentaires 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.