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Published on: December 1, 2023
A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes
Darrell M Wilson1, Bruce A Buckingham, Elizabeth L Kunselman
1Division of Pediatric Endocrinology and Diabetes, Stanford University, Stanford, California 94305-5208, USA. dwilson@stanford.edu
Insights
Continuous subcutaneous insulin infusion (CSII) is safe and effective for young children with type 1 diabetes. This method offers comparable glycemic control and quality of life to multiple daily injections (MDIs) without increased hypoglycemia risk.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Diabetes Management
Background:
- Type 1 diabetes in preschool children presents unique management challenges.
- Continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDIs) are common insulin delivery methods.
- Assessing the safety and efficacy of CSII in very young children is crucial.
Purpose of the Study:
- To evaluate the safety and feasibility of CSII in preschool children with type 1 diabetes.
- To compare glycemic control (HbA1c, continuous glucose monitoring) between CSII and MDI groups.
- To assess differences in hypoglycemia, diabetic ketoacidosis, and quality of life.
Main Methods:
- A randomized 1-year feasibility trial comparing CSII with MDI in children aged 1.7-6.1 years.
- Prospective outcomes included HbA1c, continuous glucose monitoring, severe hypoglycemia, diabetic ketoacidosis, and parent-reported quality of life.
- Nineteen children (9 CSII, 10 MDI) with at least 6 months of type 1 diabetes duration were enrolled.
Main Results:
- No significant differences in overall metabolic control, diabetes quality of life, or hypoglycemia incidence were observed between CSII and MDI groups.
- No cases of diabetic ketoacidosis occurred; one severe hypoglycemia episode happened in each group.
- All participants randomized to CSII continued using the insulin pump throughout the study.
Conclusions:
- Continuous subcutaneous insulin infusion (CSII) is a safe and effective insulin delivery method for young children with type 1 diabetes.
- CSII can be considered a viable alternative to multiple daily injections (MDIs) in this age group.
- Further research can explore long-term outcomes and broader implementation of CSII in pediatric populations.
Objective:
Our goals were to determine if continuous subcutaneous insulin infusion (CSII), compared with those continuing multiple daily injections (MDIs), can be safely used in young children, if those on CSII will have superior glycemic control, if subjects using CSII will have less hypoglycemia for their level of control, and if families using CSII will report an improved quality of life.
Research Design And Methods:
We conducted a randomized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months' duration. Prospective outcomes included measures of overall glycemic control (HbA1c and continuous glucose monitoring system), the incidence of severe hypoglycemia and diabetic ketoacidosis, the percent of glucose values below 3.9 mmol/l, and the parents' report of quality of life.
Results:
The 19 subjects' ages ranged from 1.7 to 6.1 (mean 3.6) years, duration of diabetes ranged from 0.6 to 2.6 (mean 1.4) years, and baseline HbA1c ranged from 6.7 to 9.6% (mean 7.9%). Seven subjects were male. Nine subjects were randomized to start CSII and 10 to continue on MDI. All baseline characteristics were well balanced. Overall metabolic control, diabetes quality of life, and the incidence of hypoglycemia were similar in the two groups. No subject had diabetic ketoacidosis, while one subject in each group had an episode of severe hypoglycemia. No CSII subject discontinued using the pump during or after the study.
Conclusions:
CSII can be a safe and effective method to deliver insulin in young children.
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