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A randomized, controlled study of insulin pump therapy in diabetic preschoolers
Linda A DiMeglio1, Tina M Pottorff, Sheryl R Boyd
1Pediatric Endocrinology and Diabetology, Indiana University, 702 Barnhill Drive, Indianapolis, IN 46202, USA. dimeglio@iupui.edu
Insights
Continuous subcutaneous insulin infusion (CSII) and intensive insulin injections offer similar glycemic control for preschool diabetics. Parental satisfaction was high with CSII, suggesting patient preference may guide therapy choice.
Area of Science:
- Pediatric Endocrinology
- Diabetes Management
- Metabolic Disorders
Background:
- Type 1 diabetes affects preschool-aged children, requiring intensive management.
- Continuous subcutaneous insulin infusion (CSII) and intensive insulin injections are primary treatment modalities.
- Comparing these therapies in very young children is crucial for optimizing care.
Purpose of the Study:
- To compare glycemic control, safety, and parental satisfaction between CSII and intensive insulin injections in preschool diabetic children.
- To evaluate the efficacy and tolerability of pump therapy versus injections in children under 5 years old.
- To inform treatment decisions based on clinical outcomes and patient/parent preferences.
Main Methods:
- A randomized clinical trial involving 42 preschool-aged children with diabetes.
- Participants were assigned to either CSII (n=21) or intensive insulin injection therapy (n=21).
- Key outcomes included Hemoglobin A1c (HbA1c), hypoglycemia events, blood sugar variability, BMI, and parental satisfaction over 6 months.
Main Results:
- Both CSII and injection therapy led to significant HbA1c reduction over 6 months.
- CSII showed a transiently lower HbA1c at 3 months, but groups were similar by 6 months.
- Pump therapy was safe and well-tolerated, with no significant differences in severe hypoglycemia or ketoacidosis; however, increased minor hypoglycemia was noted with pumps. Parental satisfaction with CSII was high (95% continued therapy).
Conclusions:
- CSII does not offer clinically significant glycemic control advantages over intensive insulin injections in preschool-aged children.
- Treatment decisions for CSII in this age group should consider individual patient selection and lifestyle preferences.
- Both CSII and intensive injections are safe and effective options for managing type 1 diabetes in young children.
Objective:
To compare glycemic control, safety, and parental satisfaction in preschool-aged diabetic children randomized to treatment either with continuous subcutaneous insulin infusion (CSII) or intensive insulin injection therapy.
Study Design:
This clinical trial enrolled 42 patients <5 years of age who had been diagnosed with diabetes for at least 12 months. Children were randomly assigned to CSII (n = 21) or intensive insulin injection therapy (n = 21). Hemoglobin A1c (HbA1c) level was measured at baseline, 3, and 6 months. Secondary outcomes included severe hypoglycemic events, meter-detected hypoglycemia, blood sugar variability, body mass index (BMI), and satisfaction with therapy.
Results:
Thirty-seven patients completed 6 months of therapy. There was a significant decrease in HbA1c during the study period for both groups (from 8.9% +/- 0.6% to 8.6% +/- 0.6% at 3- and 6-month visits). At 3 months, children using pumps had a significantly lower HbA1c than the injection group (8.4% vs 8.8%); however, by 6 months the two groups were similar (8.5% vs 8.7%). No differences in pre-meal blood sugar variabilities were seen between groups. Children on pumps had increases in the number of meter-detected episodes of hypoglycemia. Pump therapy was safe and well tolerated. No episodes of ketoacidosis occurred in either group, whereas one hypoglycemic seizure occurred in each group. Parents reported satisfaction with CSII, with 95% of families continuing on CSII beyond the 6-month study period.
Conclusion:
Pump therapy in preschool-aged children was not associated with clinically significant differences in glycemic control as compared with intensive injection therapy. The rationale for initiating CSII in this age group should be based on patient selection and lifestyle preference.
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