1160-P: Continuous Glucose Monitoring in Youth-Onset Type 2 Diabetes—Interim Results from Pilot Randomized Controlled 12-Week Trial

Introduction: Continuous glucose monitors (CGM) may improve diabetes self-management in youth-onset type 2 diabetes (Y-T2D), but feasibility in Y-T2D on infrequent self-monitoring blood glucose (SMBG) regimens and device burden is unclear. This is an interim analysis of primary aims to assess CGM feasibility (recruitment >60%) and acceptability (wear time >60%) and explore diabetes burden and adverse events.

Methods: This is an active 12-week randomized 2:1, two arm parallel pilot trial of CGM vs fingerstick monitoring (Con) in Y-T2D prescribed SMBG <3 times daily (not on multiple insulin injections). Diabetes distress was measured with Diabetes Distress and CGM benefit/burden scale.

Results: Between August-December 2023, recruitment rate was 60% [40 screened, 24 enrolled (14 CGM, 10 Con; 77% female, 69% Black, 14.9±3.8y, BMI: 36.2±7.7 kg/m2, HbA1c: 7.3± 2.6% (mean±SD))]. Most cited reasons for declining were reluctance to wear a device (31%) or study participation (25%). 45% (6 CGM, 5 Con) completed the study; one Con was lost to follow-up. Among CGM, wear time was 62% at 1st 6 weeks [n=11], 49% at 2nd 6 weeks [n=6], and 61% at 12 weeks [n=6], P=0.11. Among Con, blood glucoses were reported in 66% at 1st 6 weeks [n=6] and 20% at 12 weeks [n=5]. 75% of CGM users had sensors dislodged. Diabetes distress score did not change: CGM:1.8 ±0.9 to 1.3±0.1 and control: 1.2±0.2 to 1.2±0.1. No difference in mean CGM burden scale; 17±4.8 to ±7.6.

Conclusion: CGM use in Y-T2D may be feasible but device-related events were common. There is no increase in disease burden with technology use.