Managing diabetes in young children is extremely difficult, due to factors such as unpredictable insulin absorption, variable eating patterns, increased sensitivity to small amounts of insulin, parental fear of hypoglycemia, and difficulties getting the child to eat or drink. Therefore, a better way to provide insulin therapy is desirable. This study examined the benefits of insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) when compared with current insulin regimens.
A total of 26 children with type 1 diabetes between the ages of 12 and 72 months were recruited for this 6-month study. Subjects were randomly assigned to either their current insulin regimen of 2 to 3 injections per day of NPH insulin and a rapid-acting analog (current therapy group) or to receive CSII using the Medtronic MiniMed 508 (CSII group). Blood glucose levels were monitored and recorded 4 times a day, and family dynamics and quality of life (QOL) were assessed using several validated questionnaires.
Glycemic control was similar at baseline, 3 months, and 6 months between the CSII and current therapy groups. There was no significant within group change in A1C in either group from baseline to 3 months (P = .475 for CSII; P = .509 for current therapy) or from baseline to 6 months (P = .58 for CSII; P = .60 for current therapy). There were also no significant within group or between group differences in mean blood glucose (MBG). Mild/moderate hypoglycemia (blood glucose <80) was similar between the 2 treatment groups at baseline. However, CSII subjects experienced significantly more hypoglycemia before breakfast at 1 month, and before dinner at 3 and 6 months. There were no between differences in reported impact of diabetes on family quality of life. However, fathers in the CSII group reported more positive QOL changes from baseline to 6 months (P = .05).
Although this study indicated that CSII is safe and well tolerated, it did not result in improved glycemic control when compared with insulin injections. These results could be attributed to the small size of the study group (26 children only) or the low A1C levels at baseline. This trial demonstrated that CSII is comparable to multiple daily insulin injections, with no adverse effect on QOL and parental stress/distress. In fact, fathers in the CSII group reported improved QOL from baseline to 6 months, although these comparisons in the current therapy versus CSII groups were not significant. A further indicator of parent satisfaction lies in the fact that all subjects of the CSII continued with this method of insulin delivery after the study was complete. The benefits of CSII still need to be thoroughly examined. A large-scale randomized trial would be an optimal way to further assess whether CSII is preferable to insulin injection in small children.
