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

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From: The Lancet(Vol. 397, Issue 10291)
Publisher: Elsevier B.V.
Document Type: Article
Length: 497 words

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Summary 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.sub.1c), time in range (sensor glucose 3*9--10*0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with, NCT03772600. 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 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. Author Affiliation: (a) Department of Endocrinology, University Hospitals Leuven--KU Leuven, Leuven, Belgium (b) Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven and University of Hasselt, Leuven, Belgium (c) Department of Endocrinology-Diabetology-Metabolism, University Hospital Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium (d) Academic Hospital and Diabetes Research Centre, Vrije Universiteit Brussel, Brussels, Belgium (e) Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium (f) Department of Endocrinology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium (g) Department of Endocrinology, AZ Groeninge, Kortrijk, Belgium * Correspondence to: Dr Pieter Gillard, Department of Endocrinology, University Hospitals Leuven--KU Leuven, 3000 Leuven, Belgium Byline: Margaretha M Visser, MD (a), Sara Charleer, PhD (a), Steffen Fieuws, PhD (b), Prof Christophe De Block, MD (c), Robert Hilbrands, MD (d), Liesbeth Van Huffel, MD (e), Toon Maes, MD (f), Gerd Vanhaverbeke, MD (g), Eveline Dirinck, MD (c), Nele Myngheer, MD (g), Chris Vercammen, MD (f), Frank Nobels, MD (e), Prof Bart Keymeulen, MD (d), Prof Chantal Mathieu, MD (a), Pieter Gillard, MD [] (a,d)

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Gale Document Number: GALE|A664848913