Is Automated Insulin Delivery System Therapy Safe and Effective in Children Under Seven Years Old?

Abstract

Objective: 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 well-established, despite the improvements in glycemic control seen with MiniMed™ 780G therapy.

Methods: Children under seven years old with type 1 diabetes using MiniMed™ 780G pump therapy were compared with children of similar age and gender using MiniMed™ 640G insulin pump therapy and multiple-dose insulin therapy with continuous glucose monitoring systems (CGMs). CGM metrics, total daily insulin (TDI) dose, and hemoglobin A1c (HbA1c) levels were evaluated retrospectively at baseline and at the 3^rd, 6^th, and 12^th 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: 4.5-17.0 U/day). The glucose management indicator and HbA1c remained lower in the MiniMed™ 780G group at the 3^rd, 6^th, and 12^th 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 3^rd, 6^th, and 12^th months (p=0.018, p=0.017 and p=0.04, respectively) while time in range (TIR) was higher at the 3^rd, and 12^th months (p=0.026 and p=0.019, respectively) compared to other groups. The coefficient of variation (CV) of the sensor glucose and HbA1c were lower at the 12th month (p=0.008 and p=0.015, respectively) compared to both other groups. No instances of ketoacidosis or severe hypoglycemic events were observed in any of the children during the follow-up period.

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 3^rd and 12^th months, and a significant decrease in HbA1c and CV suggests that the MiniMed™ 780G system is both safe and effective for children under seven years old.