Lifestyle modification is the cornerstone of diabetes prevention but remains challenging to disseminate in the real world.¹ An increasing number of studies have shown that continuous glucose monitoring (CGM) in people with type 2 diabetes mellitus (T2DM) improves glycemia in patients treated with both insulin and non-insulin agents, in part, through behavioral and lifestyle changes.¹ However, randomized controlled trials (RCTs) on CGM-based lifestyle interventions in prediabetes settings have been limited.¹ At the EASD Annual  Meeting 2023, Dr. Chow, Yee-Kwan Elaine from the Department of Medicine and Therapeutics, the Chinese University of Hong Kong, shared her team’s interim results of the Flash LMP study.¹

The Flash LMP study was a single-center, parallel-group, non-masked RCT conducted to compare the efficacy of intermittently-scanned CGM (isCGM)-assisted lifestyle modification program (LMP) to LMP alone in improving glucose tolerance among patients with impaired glucose tolerance (IGT).¹ Patients aged 18-65 years with a body-mass index (BMI) of 18kg/m2-40kg/m2 and a 2-hour plasma glucose (PG) of 7.8mmol/L-11mmol/L in the 75g oral glucose tolerance test (OGTT) were randomized to receive an isCGM-accompanied 12-month LMP (n=89) or a 12-month LMP alone (n=88).¹ The 12-month LMP for both groups consisted of a 4-month intensive phase with weekly contact, followed by an 8-month maintenance phase with monthly contact.¹ Assessments were conducted at baseline, months 4, 8, and 12 which included OGTT with 0, 1-hour, and 2-hour PG, HbA1c, lipid profile, body weight, 3-day diet record, physical activity, and other questionnaires.¹ The primary endpoint of this study was the change in 1-hour PG from baseline.¹ Secondary endpoints included the change in fasting PG, weight, BMI, blood pressure, and heart rate from baseline.¹

As of the time of the presentation, interim results at month 4 were available. The CGM + LMP group had achieved a daily average scan frequency of 9.5 times and a sensor active time of 86%.¹ In the intention-to-treat population, patients in the CGM + LMP group had a greater improvement in 1-hour PG compared to their counterparts in the LMP group (-1.2 vs. -0.7mmol/L; mean MD=-0.46mmol/L; 95% CI: -1.04 to 0.13mmol/L).¹ The CGM + LMP group also experienced a slightly greater reduction in weight (-4.6% vs. -4.2%), systolic blood pressure (SBP) (-5.9 vs. -2.8mmHg), diastolic blood pressure (DBP) (-4.3 vs. -2.1mmHg) and heart rate (-1.3 vs. 2.4 beats/min) compared with the LMP group.¹ Furthermore, numerically greater reductions in daily energy, carbohydrates, total sugar, and fat intake were observed in the CGM + LMP group during the assessment at month 4.¹

In the per-protocol analysis, which excluded 9 patients for having <70% of active sensor time and consultation attendance, patients in the CGM + LMP group demonstrated a significant reduction in the 1-hour PG (MD=-0.6mmol/L; 95% CI: -1.18 to -0.02; p=0.04) and numerically higher reduction in weight (-5.1kg vs. -4.2kg) than patients in the LMP group.¹ The analysis also indicated a significant association between higher sensor active time and a greater percentage of weight loss in the CGM + LMP group (r=-0.364; p=0.002).¹ In terms of safety, there were only two device-related adverse events, which were mild sensitization reactions not leading to discontinuation.¹

In conclusion, isCGM as an addition to LMP may allow greater improvements in glucose tolerance among patients with IGT.¹ This ongoing trial will confirm whether these results are sustained at 12 months and beyond.¹