Continuous Glucose Monitoring Use in Youth with Type 2 Diabetes: A Pilot Randomized Study.

Abstract

Objective: Continuous glucose monitoring (CGM) enhances diabetes self-management in insulin-treated individuals. However, the feasibility, acceptability, and benefits/burdens in youth-onset type 2 diabetes (Y-T2D) who are on infrequent self-monitoring of blood glucose (SMBG) regimens remain unclear. Research Design and Methods: In Y-T2D prescribed SMBG less than or equal to twice daily, we conducted a 12-week randomized 2:1 parallel pilot trial of CGM versus fingerstick monitoring (Control). Control participants had an optional 4-week extension period to use CGM (Control-CGM). Feasibility was defined as recruitment, study participation, and retention >60% of individuals. Acceptability was defined as an individual CGM wear time of ≥60% at the end of the study. Diabetes distress and the benefits/burdens of CGM scores, hemoglobin A1c (HbA1c), and CGM-derived glycemic variables were compared at baseline and at the end of the intervention. Results: The recruitment rate was 54% (52 screened eligible, 18 CGM, 10 Control; 82% female, 68% Black, 14.9 ± 3.8 years, body mass index: 36.2 ± 7.7 kg/m², HbA1c: 7.4 ± 2.4% (mean ± standard deviation [SD]), and 8 entered the optional Control-CGM group. The most commonly cited reason for declining study participation was reluctance to wear the device (50%). The participation rate was 91% and 75%, and retention was 100% and 75% for CGM and Control-CGM, respectively. A majority of Y-T2D had ≥60% wear time at the end of the study (CGM: 56% and Control-CGM: 83%). Wear time declined during the study (1st month: 71 ± 31% vs. 2nd month: 55 ± 32% vs. 3rd month: 38 ± 34%, P = 0.003). There were no significant changes in glycemia, CGM burden/benefits, or diabetes distress scores (P > 0.05). Minor sensor adhesion adverse events were common (75%) causes of reduced wear time. Conclusion: CGM was a feasible and acceptable adjunct to diabetes self-care among >50% of Y-T2D prescribed infrequent SMBG monitoring. Unwillingness to wear a device and social stigma impeded device use. Additional research is needed to mitigate the high rates of skin adhesion-related adverse events in this population.