Elsevier

The Journal of Pediatrics

Volume 145, Issue 3, September 2004, Pages 380-384
The Journal of Pediatrics

Original Articles
A randomized, controlled study of insulin pump therapy in diabetic preschoolers

https://doi.org/10.1016/j.jpeds.2004.06.022Get rights and content

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.

Section snippets

Research design and methods

The study was undertaken at the James Whitcomb Riley Hospital for Children in Indianapolis, Indiana. The Indiana University Institutional Review Board approved this study protocol. All parents of participating children signed consent forms. Children were eligible for study if they were < 5 years of age, had been diagnosed with type 1 diabetes for at least 12 months, and received two or more insulin injections daily. Families were selected based on a history of compliance with physician visits

Statistical methods

Statistical evaluation was performed using Microsoft Excel 2000 (for descriptive statistics) and the Statistical Package for the Social Sciences, version 11.0 (for other analyses; SPSS Inc, Chicago, Ill). Data are expressed as means ± standard deviations. t tests were used for comparisons between groups when the data were normally distributed. The Mann-Whitney U test was used for data that were not normally distributed. P values of <.05 were considered evidence of significant differences.

Results

Of 50 eligible patients, 42 were randomized. Twenty-one were randomized to insulin injections, 21 to pump therapy. Two children had fathers with type I diabetes (1 in pump group, 1 in injection group). No family had prior experience with insulin pump therapy. Characteristics of the patients at the time of randomization are outlined in the Table. The mean HbA1c for the prior year for both groups was 9.0% ± 0.6%. There were no significant differences between groups.

One patient randomized to

Discussion

Bougneres et al published the first evaluation of CSII in a group of children with diabetes <5 years of age who had “marked metabolic instability” on conventional therapy.9 Conventional therapy was defined as one to two daily injections of purified porcine insulin. Over a 6-month study period, they found improvement both in HbA1c and in the frequency of hypoglycemic episodes and that pump therapy did not interfere with normal toddler activities. Their study focused on children who were poorly

References (18)

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Supported by grants from the Indiana University Diabetes Research and Training Center and the Juvenile Diabetes Research Foundation. Medtronic/MiniMed provided pumps and disposable supplies. Roche Diagnostics provided meters, strips, and fax modems.

Presented in part as an abstract at the 2003 APS-SPR Meetings in Seattle, Washington. (DiMeglio LA, Boyd SR, Pottorff TM, Fineberg N, Eugster EA. A randomized, controlled study of insulin pump therapy in diabetic toddlers. Pediatric Research. 2003;52(suppl):739A.)

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