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Long Term Effects of Diabetes of Very Young Children

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT00707629
First received: June 30, 2008
Last updated: February 29, 2016
Last verified: February 2016
  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

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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Diabetes Control [ Time Frame: Data Collected at each study visit ] [ Designated as safety issue: No ]
    HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar

  • Ease of Injections versus Insulin pump Therapy [ Time Frame: Conclusion of study ] [ Designated as safety issue: No ]
    Mechanical issues, site infections and errors of insulin administration


Enrollment: 25
Study Start Date: August 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years   (Child)
Genders Eligible for Study:   Both
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Indiana
Riley Hospital for Children
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: Linda DiMeglio, MD, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00707629     History of Changes
Other Study ID Numbers: 0507-18 
Study First Received: June 30, 2008
Last Updated: February 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on December 06, 2016