Long Term Effects of Diabetes of Very Young Children - Full Text View

Sponsors and Collaborators:	Indiana University Juvenile Diabetes Research Foundation
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00707629

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

Condition
Type 1 Diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Long Term Effects of Diabetes of Very Young Children

Further study details as provided by Indiana University:

Estimated Enrollment:	40
Study Start Date:	August 2005
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.
Daily Injections Children must have type 1 diabetes for at least five years and diagnosed prior to the age of 5. Children must receive at least 2 daily injections of insulin.

Eligibility

Ages Eligible for Study:	6 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707629

Contacts

Contact: Stephanie Stein, FNP

317-274-3889

sestein@iupui.edu

Locations

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

Sponsors and Collaborators

Indiana University

Juvenile Diabetes Research Foundation

Investigators

Principal Investigator:

Linda A DiMeglio, MD

Indiana University/Riley Hospital for Children

More Information

Responsible Party:	Indiana University ( Linda A. DiMeglio, MD )
Study ID Numbers:	0507-18
Study First Received:	June 30, 2008
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00707629
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

type 1 diabetes
neurocognitive measures
behavioral measures

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009