Margaretha M Visser1, Sara Charleer1, Steffen Fieuws2, Christophe De Block3, Robert Hilbrands4, Liesbeth Van Huffel5, Toon Maes6, Gerd Vanhaverbeke7, Eveline Dirinck3, Nele Myngheer7, Chris Vercammen6, Frank Nobels5, Bart Keymeulen4, Chantal Mathieu1, Pieter Gillard8. 1. Department of Endocrinology, University Hospitals Leuven-KU Leuven, Leuven, Belgium. 2. Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven and University of Hasselt, Leuven, Belgium. 3. Department of Endocrinology-Diabetology-Metabolism, University Hospital Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. 4. Academic Hospital and Diabetes Research Centre, Vrije Universiteit Brussel, Brussels, Belgium. 5. Department of Endocrinology, OLV Hospital Aalst, Aalst, Belgium. 6. Department of Endocrinology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium. 7. Department of Endocrinology, AZ Groeninge, Kortrijk, Belgium. 8. 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.
Abstract
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 (HbA1c), 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 ClinicalTrials.gov, 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<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users. 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.
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 (HbA1c), 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 ClinicalTrials.gov, 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<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users. 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.
Authors: Erik H Serné; Stéphane Roze; Maria I Buompensiere; William J Valentine; Simona De Portu; Harold W de Valk Journal: Adv Ther Date: 2022-02-28 Impact factor: 3.845
Authors: Richard I G Holt; J Hans DeVries; Amy Hess-Fischl; Irl B Hirsch; M Sue Kirkman; Tomasz Klupa; Barbara Ludwig; Kirsten Nørgaard; Jeremy Pettus; Eric Renard; Jay S Skyler; Frank J Snoek; Ruth S Weinstock; Anne L Peters Journal: Diabetologia Date: 2021-12 Impact factor: 10.122