Overview

A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
Summary
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital of Eastern Ontario
Treatments:
Insulin
Criteria
Inclusion Criteria:

- New onset type 1 diabetes

- Less than 48 hours since first insulin injection

- Child and/or parent able to read and write English

- Family intends to continue treatment at our institution for the next two years

- Informed consent from adolescents greater than 16 years of age, or if less than 16
years, informed consent from the parent/guardian with assent from the child.

Exclusion Criteria:

- Chronic medical conditions other than treated hypothyroidism or mild asthma

- Concerns of the diabetes team regarding future treatment adherence making twice daily
insulin preferable to the split evening injection regimen (e.g., cognitive impairment,
severe family dysfunction).