Long Term Effects of Diabetes of Very Young Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707629
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : March 1, 2016
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Linda DiMeglio, MD, 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.

Condition or disease
Type 1 Diabetes

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long Term Effects of Diabetes of Very Young Children
Study Start Date : August 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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

  2. Ease of Injections versus Insulin pump Therapy [ Time Frame: Conclusion of study ]
    Mechanical issues, site infections and errors of insulin administration

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707629

United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Juvenile Diabetes Research Foundation
Principal Investigator: Linda A DiMeglio, MD Indiana University/Riley Hospital for Children

Responsible Party: Linda DiMeglio, MD, MD, Indiana University Identifier: NCT00707629     History of Changes
Other Study ID Numbers: 0507-18
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Linda DiMeglio, MD, Indiana University:
type 1 diabetes
neurocognitive measures
behavioral measures

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases