This trial is active, not recruiting.

Condition type 1 diabetes
Sponsor Indiana University
Collaborator Juvenile Diabetes Research Foundation
Start date January 2004
Trial size 50 participants
Trial identifier NCT00727220, 0312-13


The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Children starting insulin pump therapy within six months. Children must be diagnosed with type 1 diabetes for at least one year and under the age of 5 years.
Children must be diagnosed with diabetes for at least one year at the time of the study. They must be under the age of 5 and receive at least 2 insulin injections daily.

Eligibility Criteria

Male or female participants from 2 years up to 5 years old.

Inclusion Criteria: 1. Children with Type I diabetes: - 24 who have had insulin pump therapy recommended by their primary diabetes caretaker. - 13 using NPH or Lente insulin plus rapid acting insulin - 13 using glargine insulin 2. Children must be 5 years of age or less at the time of entry into the study. 3. Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry. 4. Children must be receiving two or more insulin injections daily. 5. In order to be tested, the child must not have had any moderate or severe hypoglycemia (blood glucose <60 mg/dl) for the 24 hours preceding the testing as documented by home glucose testing. Exclusion Criteria: 1. Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase. 2. Children must not have any other chronic illness in addition to diabetes.

Additional Information

Official title A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM
Principal investigator Linda DeMeglio, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Indiana University.