Long Term Effects of Diabetes of Very Young Children

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00707629
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes Control	Data Collected at each study visit	HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar
Ease of Injections versus Insulin pump Therapy	Conclusion of study	Mechanical issues, site infections and errors of insulin administration

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States