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Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial

Ajjan, Ramzi A.; Heller, Simon R.; Everett, Colin C.; Vargas-Palacios, Armando; Higham, Ruchi; Sharples, Linda; Gorog, Diana A.; Rogers, Alice; Reynolds, Catherine; Fernandez, Catherine; Rodrigues, Pedro; Sathyapalan, Thozhukat; Storey, Robert F.; Stocken, Deborah D.

Authors

Ramzi A. Ajjan

Simon R. Heller

Colin C. Everett

Armando Vargas-Palacios

Ruchi Higham

Linda Sharples

Diana A. Gorog

Alice Rogers

Catherine Reynolds

Catherine Fernandez

Pedro Rodrigues

Robert F. Storey

Deborah D. Stocken



Abstract

OBJECTIVE To analyze the impact of modern glucose-monitoring strategies on glycemic and patient-related outcomes in individuals with type 2 diabetes (T2D) and recent myocardial infarction (MI) and assess cost effectiveness. RESEARCH DESIGN AND METHODS LIBERATES was a multicenter two-arm randomized trial comparing self-monitoring of blood glucose (SMBG) with intermittently scanned continuous glucose monitoring (isCGM), also known as flash CGM, in individuals with T2D and recent MI, treated with insulin and/or a sulphonylurea before hospital admission. The primary outcome measure was time in range (TIR) (glucose 3.9–10 mmol/L/day) on days 76–90 post-randomization. Secondary and exploratory outcomes included time in hypoglycemia, hemoglobin A1c (HbA1c), clinical outcome, quality of life (QOL), and cost effectiveness. RESULTS Of 141 participants randomly assigned (median age 63 years; interquartile range 53, 70), 73% of whom were men, isCGM was associated with increased TIR by 17 min/day (95% credible interval 2105 to +153 min/day), with 59% probability of benefit. Users of isCGM showed lower hypoglycemic exposure (<3.9 mmol/L) at days 76–90 (280 min/day; 95% CI 2118, 243), also evident at days 16–30 (228 min/day; 95% CI 292, 2). Compared with baseline, HbA1c showed similar reductions of 7 mmol/mol at 3 months in both study arms. Combined glycemic emergencies and mortality occurred in four isCGM and seven SMBG study participants. QOL measures marginally favored isCGM, and the intervention proved to be cost effective. CONCLUSIONS Compared with SMBG, isCGM in T2D individuals with MI marginally increases TIR and significantly reduces hypoglycemic exposure while equally improving HbA1c, explaining its cost effectiveness. Studies are required to understand whether these glycemic dif-ferences translate into longer-term clinical benefit.

Citation

Ajjan, R. A., Heller, S. R., Everett, C. C., Vargas-Palacios, A., Higham, R., Sharples, L., …Stocken, D. D. (2023). Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial. Diabetes Care, 46(2), 441-449. https://doi.org/10.2337/dc22-1219

Journal Article Type Article
Acceptance Date Nov 2, 2022
Online Publication Date Dec 14, 2022
Publication Date Feb 1, 2023
Deposit Date Dec 21, 2022
Publicly Available Date Jan 3, 2023
Journal Diabetes Care
Print ISSN 0149-5992
Electronic ISSN 1935-5548
Publisher American Diabetes Association
Peer Reviewed Peer Reviewed
Volume 46
Issue 2
Article Number dc221219
Pages 441-449
DOI https://doi.org/10.2337/dc22-1219
Keywords Advanced and Specialized Nursing; Endocrinology, Diabetes and Metabolism; Internal Medicine
Public URL https://hull-repository.worktribe.com/output/4160700

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