A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes.
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.


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.
Wilson
Darrell M
DM
Division of Pediatric Endocrinology and Diabetes, Stanford University, Stanford, California 94305-5208, USA. dwilson@stanford.edu
Buckingham
Bruce A
BA
Kunselman
Elizabeth L
EL
Sullivan
Mary M
MM
Paguntalan
Helen U
HU
Gitelman
Stephen E
SE
D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005240:Feasibility Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000517:prevention & control; D007223:Infant; D007332:Insulin Infusion Systems; D018670:Monitoring, Ambulatory; D015203:Reproducibility of Results; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin