The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.

Abstract

BackgroundContinuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes.MethodsChild–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures.FindingsFifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001).ConclusionThe use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.