Status:
COMPLETED
A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Lead Sponsor:
Children's Hospital of Eastern Ontario
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
Brief 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 (insu...
Detailed Description
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times dail...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 1996
Trial Type :
INTERVENTIONAL
End Date :
January 1 2001
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00146484
Start Date
April 1 1996
End Date
January 1 2001
Last Update
September 7 2005
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1