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OpenTrials
Completed

NCT Number: NCT00727220

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

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.

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with Type I diabetes:
  • Children must be 5 years of age or less at the time of entry into the study.
  • Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry.
  • Children must be receiving two or more insulin injections daily.

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.

Treatment and study plan

Primary outcomes

  1. Change in HgBA1c

    Time frame: Baseline and 6 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2003
Study completion
2004
First posted
Aug 1, 2008
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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