Long Term Effects of Diabetes of Very Young Children

Type 1 Diabetes Clinical Trial

Official title:

Long Term Effects of Diabetes of Very Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707629
• Other study ID #: 0507-18
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: February 29, 2016
• Start date: August 2005
• Est. completion date: January 2010

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years

• Children recruited on pumps must have used pump therapy for at least 3 years

• Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years.

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 with the exception of treated autoimmune hypothyroidism.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Control	HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar	Data Collected at each study visit	No
Primary	Ease of Injections versus Insulin pump Therapy	Mechanical issues, site infections and errors of insulin administration	Conclusion of study	No