Long Term Effects of Diabetes of Very Young Children

February 29, 2016 updated by: Linda DiMeglio, MD, Indiana University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children between ages 6 and 10. Diagnosed with type 1 diabetes prior to the age of 5 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Control
Time Frame: 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
Data Collected at each study visit
Ease of Injections versus Insulin pump Therapy
Time Frame: Conclusion of study
Mechanical issues, site infections and errors of insulin administration
Conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Juvenile Diabetes Research Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 1, 2008

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0507-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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