Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial

Background: Tight glycemic control delays the long‐term complications of type 1 diabetes mellitus (T1DM) but increases the risk for hypoglycemia. The continuous glucose‐monitoring system (CGMS) provides blood glucose (BG) readings every 5 min, and its accuracy and reliability has been established in adults. However, there are limited data on its efficacy and safety in children. The purpose of this study was to determine if CGMS use improves metabolic control in children with T1DM. Methods: Twenty‐seven children (12 male) with T1DM participated in this single‐blind, randomized, controlled trial. Participants (age: 11.4 ± 3.7 (mean ± SD) yr, range: 7–17 yr) were randomized to an intervention group (n = 18) or a control group (n = 9). Both groups wore the CGMS for 72‐h periods at 0, 2, and 4 months. Adjustments in therapy for the intervention group were based on both CGMS and self‐monitoring of BG (SMBG) data, while only SMBG data were used for the control group. Hemoglobin A1c (HbA1c) was determined at 0, 2, 4, and 6 months. The change in HbA1c from 0 to 6 months (HbA1cΔ1−4) and mean daily area under the CGMS curve for glucose