Long Term Effects of Diabetes of Very Young Children

Indiana University

Status: Completed

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT00707629

0507-18

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

Insulin Pump Therapy

Description:

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.