Is Automated Insulin Delivery System Therapy Safe and Effectıve in Children Under 7 Years Old?
Nihal Gul Uslu, Deniz Ozalp Kizilay, Gunay Demir, Yasemin Atik Altinok, Sukran Darcan, Samim Ozen, Damla GöksenEge University School of Medicine, Department of Pediatrics, Division of Pediatric EndocrinologyINTRODUCTION: This study aims to evaluate the off-label use of the MiniMed™ 780G system in children under seven years old, as clinical outcomes in this age group are less established despite the improvements in glycemic control seen with MiniMed™ 780G therapy.
METHODS: Children under seven years old with type 1 diabetes (T1D) using MiniMed™ 780G pump therapy were retrospectively compared with children of similar age and gender using MiniMed™ 640G insulin pump therapy and multiple-dose insulin (MDI) therapy with continuous glucose monitoring systems (CGMs). CGM metrics, total daily insulin dose (TDI), and HbA1c levels were evaluated retrospectively at baseline and at the 3rd, 6th, and 12th months.
RESULTS: At the initiation of MiniMed™ 780G therapy, the mean age was 5,25±1,22 years (range: 2,8–6,8 years), and the mean TDI was 10,12±4,34 U/day (range: 4,5–17 U/day). The glucose management indicator (GMI) and HbA1c remained lower in the MiniMed™ 780G group at the 3rd, 6th, and 12th months compared to baseline (p=0,009 and p<0,001, respectively). In the MiniMed™ 780G group, Time Above Range (TAR) was significantly lower at the 3rd, 6th, and 12th months (p=0,018, 0,017, and 0,04, respectively), and Time in Range (TIR) was higher at the 3rd and 12th months (p=0,026 and 0,019, respectively). The coefficient of variation (CV) and HbA1c were lower at the 12th month (p=0,008 and 0,015, respectively) compared to the other groups. No instances of ketoacidosis or severe hypoglycemic events were observed in any of the children during the follow-up period.
DISCUSSION AND CONCLUSION: The absence of significantly higher levels of hypoglycemia compared to other groups at any time point, along with a significant decrease in TAR across all time points, a significant increase in TIR at the 3rd and 12th months, and a significant decrease in HbA1c and CV, indicates that the MiniMed™ 780G system is both safe and effective for children under seven years old.
Manuscript Language: English
