IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non‐insulin Antihyperglycaemic ThErapy (IMMEDIATE): A randomized controlled trial

• Published in: Diabetes, obesity & metabolism Vol. 25; no. 4; pp. 1024 - 1031
• Main Authors: Aronson, Ronnie, Brown, Ruth E., Chu, Lisa, Bajaj, Harpreet S., Khandwala, Hasnain, Abitbol, Alexander, Malakieh, Nadia, Goldenberg, Ronald
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.04.2023; Wiley Subscription Services, Inc
• Subjects: Adult; Blood Glucose; Blood Glucose Self-Monitoring; Clinical trials; continuous glucose monitoring; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2; Glucose; Glucose monitoring; glycaemic control; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Middle Aged; Patient satisfaction; randomized trial; type 2 diabetes; glycaemic control; type 2 diabetes; continuous glucose monitoring; randomized trial
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14949

Aim To examine the efficacy and patient satisfaction of intermittently scanned continuous glucose monitoring (isCGM) in adults using non‐insulin therapies for the management of type 2 diabetes. Materials and Methods The IMMEDIATE study was a multisite, open label, randomized controlled trial with follow‐up at 16 weeks. Adults with type 2 diabetes using at least one non‐insulin therapy, with an HbA1c of 7.5% or higher (≥ 58 mmol/mol), were randomized 1:1 to receive an isCGM device plus diabetes self‐management education (isCGM + DSME) or DSME alone. Enrolment occurred from 8 September 2020 to 24 December 2021. The primary outcome was percentage mean time in range (TIR), in the final 2‐week period, measured via blinded CGM. Results One hundred and sixteen participants were randomized (mean age, 58 years; diabetes duration, 10 years; mean HbA1c, 8.6% [70 mmol/mol]). At 16 weeks of follow‐up, the isCGM and DSME arm had a significantly greater mean TIR by 9.9% (2.4 hours) (95% CI, −17.3% to −2.5%; P < .01), significantly less time above range by 8.1% (1.9 hours) (95% CI, 0.5% to 15.7%; P = .037), and a greater reduction in mean HbA1c by 0.3% (3 mmol/mol) (95% CI, 0% to 0.7%; P = .048) versus the DSME arm. Time below range was low and not significantly different between groups and hypoglycaemic events were few in both groups. Glucose monitoring satisfaction was higher among isCGM users (adjusted difference −0.5 [95% CI, −0.7 to −0.3], P < .01). Conclusions The IMMEDIATE study has shown that among non‐insulin–treated individuals with type 2 diabetes, use of isCGM is associated with an improvement in glycaemic outcomes.