Long Term Effects of Diabetes of Very Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Insulin Pump Therapy

Children on insulin pumps for at least three years. Subjects must have type 1 diabetes for at least five years and diagnosed under the age of 5.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No