Expired Study
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Indianapolis, Indiana 46202


Purpose:

To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life. It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.


Criteria:

Inclusion Criteria: - Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years - Children recruited on pumps must have used pump therapy for at least 3 years - Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years. Exclusion Criteria: - 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. - Children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.


NCT ID:

NCT00707629


Primary Contact:

Principal Investigator
Linda A DiMeglio, MD
Indiana University/Riley Hospital for Children


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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