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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT00727220
First received: July 30, 2008
Last updated: April 1, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Estimated Enrollment: 50
Study Start Date: January 2004
Groups/Cohorts
Insulin Pump Therapy
Children starting insulin pump therapy within six months. Children must be diagnosed with type 1 diabetes for at least one year and under the age of 5 years.
Insulin Injections
Children must be diagnosed with diabetes for at least one year at the time of the study. They must be under the age of 5 and receive at least 2 insulin injections daily.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children diagnosed with type 1 diabetes for at least one year at the time of study. In addition, children must be under the age of 5 years

Criteria

Inclusion Criteria:

  1. Children with Type I diabetes:

    • 24 who have had insulin pump therapy recommended by their primary diabetes caretaker.
    • 13 using NPH or Lente insulin plus rapid acting insulin
    • 13 using glargine insulin
  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.
  5. In order to be tested, the child must not have had any moderate or severe hypoglycemia (blood glucose <60 mg/dl) for the 24 hours preceding the testing as documented by home glucose testing.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727220

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 DeMeglio, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Linda DiMeglio, MD, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00727220     History of Changes
Other Study ID Numbers: 0312-13
Study First Received: July 30, 2008
Last Updated: April 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
type 1 diabetes
continuous glucose sensor monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013