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

This study has been completed.
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: May 17, 2017
Last verified: May 2017
  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:


Further study details as provided by Linda DiMeglio, MD, Indiana University:

Primary Outcome Measures:
  • Change in HgBA1c [ Time Frame: Baseline and 6 months ]

Enrollment: 42
Study Start Date: November 1999
Study Completion Date: January 2004
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts
Insulin Pump Therapy
Children starting insulin pump therapy
Insulin Injections
Children remaining on insulin injections.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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:
  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.

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
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: 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

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
Results First Received: February 29, 2016
Last Updated: May 17, 2017

Keywords provided by Linda DiMeglio, MD, Indiana University:
type 1 diabetes
continuous glucose sensor monitoring

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

ClinicalTrials.gov processed this record on June 28, 2017