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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

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posted on 2022-12-14, 17:29 authored by Ramzi A. Ajjan, Simon R Heller, Colin C. Everett, Armando Vargas PalaciosArmando Vargas Palacios, Ruchi Higham, Linda Sharples, Diana A Gorog, Alice Rogers, Catherine B. Reynolds, Catherine Fernandez, Pedro Rodrigues, Thozhukat Sathyapalan, Robert F Storey, Deborah Stocken

  

Objective

Analyse 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 also assess cost effectiveness. 

Research design and methods

LIBERATES was a multicentre, two-arm randomised 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 sulphonylurea prior to hospital admission. 

The primary outcome measure was time in range (TIR; glucose 3.9-10 mmol/l)/day on days 76-90 post randomisation. Secondary and exploratory outcomes included time in hypoglycemia, hemoglobin (Hb)A1c, clinical outcome, quality of life (QoL) and cost effectiveness. 

Results 

Of 141 participants aged [median 63 IQR (53, 70) years, 73% males] randomised, isCGM was associated with increased TIR by 17mins/day (95% credible interval -105, +153mins/day) with 59% probability for a benefit. Users of isCGM showed lower hypoglycemic exposure (<3.9 mmol/l) at days 76-90 [-80min/day (95% CI: -118, -43)], also evident at days 16-30 [-28min/day (-92, 2)]. Compared with baseline, HbA1c showed similar reductions of 7 mmol/mol at 3 months in both study arms. 

Combined glycemic emergencies/mortality occurred in 4 isCGM and 7 SMBG study participants. QoL measures marginally favoured 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 differences translate into longer term clinical benefit. 

Funding

Abbott Laboratories

Department of Health > National Institute for Health Research

History

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