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

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00727220
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Primary Completion: 2003-04
• Study Completion: 2004-01
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Results First Submitted: 2016-02-29
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-17
• Last Update Submitted: 2017-05-17
• Results First Posted: 2017-05-19
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HgBA1c	Baseline and 6 months

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States