Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-11-30

Study Completion Date

2004-01-31

Brief Summary

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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.

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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

PROSPECTIVE

Study Groups

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Insulin Pump Therapy

Children starting insulin pump therapy

No interventions assigned to this group

Insulin Injections

Children remaining on insulin injections.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Children with Type I diabetes:
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.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes