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.