Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study

Background and Objective Outcomes of using flash glucose monitoring have been reported in adults. This trial evaluated use in children and teenagers with type 1 diabetes. Methods Prospective, single arm, non‐inferiority multicenter study to demonstrate equivalence of time in range (TIR [70‐180 mg/dL]) by comparing 14‐day masked sensor wear (baseline) with self‐monitored blood glucose (SMBG) testing to the final 14‐days of 8‐week open‐label system use for diabetes self‐management including insulin dosing. Results A total of 76 children and teenagers (46.1% male; age 10.3 ± 4.0 years, type 1 diabetes duration 5.4 ± 3.7 years; mean ± SD) from 10 sites participated. TIR improved significantly by 0.9 ± 2.8 h/d ( P = 0.005) vs SMBG baseline. Time in hyperglycemia (>180 mg/dL) reduced by −1.2 ± 3.3 h/d ( P = 0.004). HbA1c reduced by −0.4% (−4.4 mmol/mol), from 7.9 ± 1.0% (62.9 ± 11.2 mmol/mol) baseline to 7.5 ± 0.9% (58.5 ± 9.8 mmol/mol) study end ( P < 0.0001) with reductions across all age‐subgroups (4‐6, 7‐12 and 13‐17 years). Time in hypoglycemia (<70 mg/dL) was unaffected. Throughout the treatment phase system utilization was 91% ± 9; sensor scanning was 12.9 ± 5.7/d with SMBG dropping to 1.6 ± 1.9 from 7.7 ± 2.5/d. Diabetes Treatment Satisfaction Questionnaire “Total Treatment Satisfaction” score improved for parents ( P < 0.0001) and teenagers ( P < 0.0001). No adverse events ( n = 121) were associated with sensor accuracy, 42 participants experienced sensor insertion signs and symptoms. Three participants experienced three mild device‐related (sensor wear) symptoms, resolving quickly (without treatment [ n = 2], non‐prescription antihistamines [ n = 1]). Conclusions Children with diabetes improved glycemic control safely and effectively with short‐term flash glucose monitoring compared to use of SMBG in a single arm study.