Long Term Effects of Diabetes of Very Young Children
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|ClinicalTrials.gov Identifier: NCT00707629|
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : March 1, 2016
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life.
It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.
|Condition or disease|
|Type 1 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Long Term Effects of Diabetes of Very Young Children|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Insulin Pump Therapy
Children on insulin pumps for at least three years. Subjects must have type 1 diabetes for at least five years and diagnosed under the age of 5.
- Diabetes Control [ Time Frame: Data Collected at each study visit ]HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar
- Ease of Injections versus Insulin pump Therapy [ Time Frame: Conclusion of study ]Mechanical issues, site infections and errors of insulin administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707629
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Linda A DiMeglio, MD||Indiana University/Riley Hospital for Children|