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

Type 1 Diabetes Clinical Trial

Official title:

A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727220
• Other study ID #: 0312-13
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: May 17, 2017
• Start date: November 1999
• Est. completion date: January 2004

Study information

• Verified date: May 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2004
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HgBA1c		Baseline and 6 months