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Is Automated Insulin Delivery System Therapy Safe and Effective in Children Under Seven Years Old?
Nihal Gul Uslu1, Deniz Ozalp Kizilay1, Gunay Demir1
1Ege University School of Medicine, Department of Pediatrics, Division of Pediatric Endocrinology.
Insights
The MiniMed™ 780G system demonstrates safety and effectiveness in children under seven with type 1 diabetes. This insulin pump therapy improved glycemic control, reducing time above range and HbA1c without increasing hypoglycemia.
Area of Science:
- Pediatric Endocrinology
- Diabetes Technology
- Metabolic Disorders
Background:
- Off-label use of advanced insulin pump systems in younger children requires careful evaluation.
- Clinical outcomes for type 1 diabetes management in children under seven are less established.
- The MiniMed™ 780G system offers potential improvements in glycemic control.
Purpose of the Study:
- To assess the safety and efficacy of the MiniMed™ 780G system in children under seven years old with type 1 diabetes.
- To compare glycemic control metrics between the MiniMed™ 780G system and other diabetes management approaches in this age group.
Main Methods:
- Retrospective comparison of children under seven with type 1 diabetes using MiniMed™ 780G versus MiniMed™ 640G or multiple-dose insulin therapy with CGM.
- Evaluation of continuous glucose monitoring (CGM) metrics, total daily insulin (TDI), and hemoglobin A1c (HbA1c) at baseline and 3, 6, and 12 months.
- Analysis included glucose management indicator, time above range (TAR), time in range (TIR), and coefficient of variation (CV).
Main Results:
- The MiniMed™ 780G group showed significantly lower HbA1c and glucose management indicator compared to baseline.
- Time above range (TAR) was significantly reduced, and time in range (TIR) was significantly increased in the MiniMed™ 780G group compared to controls.
- No severe hypoglycemia or ketoacidosis events occurred; the coefficient of variation (CV) for sensor glucose and HbA1c was lower at 12 months.
Conclusions:
- The MiniMed™ 780G system is safe and effective for managing type 1 diabetes in children under seven.
- The system achieved significant improvements in glycemic control, including reduced TAR and increased TIR, without compromising safety.
- Findings support the off-label use of the MiniMed™ 780G system in this pediatric population.
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 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: 4.5-17.0 U/day). The glucose management indicator 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, p=0.017 and p=0.04, respectively) while time in range (TIR) was higher at the 3rd, and 12th 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 3rd and 12th 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.
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