Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Indiana University.
Recruitment status was Active, not recruiting
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University
First received: July 30, 2008
Last updated: April 1, 2012
Last verified: April 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||2 Years to 5 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
Children with Type I diabetes:
- 24 who have had insulin pump therapy recommended by their primary diabetes caretaker.
- 13 using NPH or Lente insulin plus rapid acting insulin
- 13 using glargine insulin
- 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.
- In order to be tested, the child must not have had any moderate or severe hypoglycemia (blood glucose <60 mg/dl) for the 24 hours preceding the testing as documented by home glucose testing.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727220
|Riley Hospital for Children
|Indianapolis, Indiana, United States, 46202 |
Juvenile Diabetes Research Foundation
||Linda DeMeglio, MD
||Indiana University School of Medicine
No publications provided
||Linda DiMeglio, MD, MD, Indiana University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 30, 2008
||April 1, 2012
||United States: Institutional Review Board
Keywords provided by Indiana University:
type 1 diabetes
continuous glucose sensor monitoring
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 20, 2014
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Physiological Effects of Drugs