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Published on: December 1, 2023
A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes
Larry A Fox1, Lisa M Buckloh, Shiela D Smith
1Nemours Children's Clinic, NE Florida Pediatric Diabetes Center, 807 Children's Way, Jacksonville, FL 32207, USA. lfox@lwpes.org
Insights
Continuous subcutaneous insulin infusion (CSII) is safe for young children with type 1 diabetes and may improve quality of life. However, CSII did not enhance diabetes control compared to injections and led to more mild hypoglycemia.
Area of Science:
- Pediatric Endocrinology
- Metabolic Disorders
- Diabetes Management
Background:
- Type 1 diabetes (T1D) management in young children presents unique challenges.
- Insulin pump therapy, or continuous subcutaneous insulin infusion (CSII), is an alternative to multiple daily injections.
- Assessing the impact of CSII on glycemic control and family well-being in this age group is crucial.
Purpose of the Study:
- To evaluate the efficacy and safety of CSII compared to conventional insulin injections in children aged 1-6 years with T1D.
- To assess the effects of CSII on diabetes control, hypoglycemia, quality of life (QOL), and parental adjustment.
Main Methods:
- A randomized controlled trial involving 26 children with T1D, comparing CSII to standard injection therapy for 6 months.
- Key outcomes measured included HbA(1c), mean blood glucose (MBG), hypoglycemia frequency, diabetes-related QOL, and parental adjustment.
- Participants were monitored for changes from baseline over the study period.
Main Results:
- No significant differences in HbA(1c) or MBG were observed between CSII and injection groups at 6 months.
- CSII was associated with an increase in mild/moderate hypoglycemia, but severe events remained similar.
- Improvements in diabetes-related QOL were noted in fathers of children on CSII, while mothers on conventional therapy experienced increased distress.
Conclusions:
- CSII is a safe and well-tolerated treatment option for very young children with T1D.
- While CSII may offer benefits to parental QOL, it did not demonstrate superior glycemic control over injections in this cohort.
- Careful consideration of benefits, risks, and realistic expectations is essential before initiating CSII in this population.
Objective:
This study assesses the effects of insulin pump therapy on diabetes control and family life in children 1-6 years old with type 1 diabetes.
Research Design And Methods:
Twenty-six children with type 1 diabetes for >/=6 months were randomly assigned to current therapy (two or three shots per day using NPH insulin and rapid-acting analog) or continuous subcutaneous insulin infusion (CSII) for 6 months. After 6 months, current therapy subjects were offered CSII. Changes in HbA(1c), mean blood glucose (MBG), hypoglycemia frequency, diabetes-related quality of life (QOL), and parental adjustment were recorded.
Results:
Eleven subjects from each group completed the trial (age 46.3 +/- 3.2 months [means +/- SE]). At baseline, there were no differences between groups in HbA(1c), MBG, age, sex, diabetes duration, or parental QOL. Mean HbA(1c), MBG, and parental QOL were similar between groups at 6 months. Mean HbA(1c) and MBG did not change from baseline to 6 months in either group. The frequency of severe hypoglycemia, ketoacidosis, or hospitalization was similar between groups at any time period. Subjects on CSII had more fasting and predinner mild/moderate hypoglycemia at 1 and 6 months. Diabetes-related QOL improved in CSII fathers from baseline to 6 months. Psychological distress increased in current therapy mothers from baseline to 6 months. All subjects continued CSII after study completion.
Conclusions:
CSII is safe and well tolerated in young children with diabetes and may have positive effects on QOL. CSII did not improve diabetes control when compared with injections, despite more mild/moderate hypoglycemia. The benefits and realistic expectations of CSII should be thoroughly examined before starting this therapy in very young children.
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