Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes
Recruitment status was Active, not recruiting
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.
Type 1 Diabetes
|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|
|Study Start Date:||January 2004|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727220
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Linda DeMeglio, MD||Indiana University School of Medicine|