| Trial ID: | L5172 |
| Source ID: | NCT00146484
|
| Associated Drug: |
Twice Daily Versus Three Times Daily Insulin Injections
|
| Title: |
A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Twice Daily versus Three Times Daily Insulin Injections
|
| Outcome Measures: |
Primary: * Hemoglobin A1c over the first 24 months of diabetes | Secondary: * Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes|* Frequency of morning hyperglycemia over the first 24 months of diabetes|* Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)|* Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes|* Family Functioning (Family Environment Scale)over the first 24 months of diabetes
|
| Sponsor/Collaborators: |
Sponsor: Children's Hospital of Eastern Ontario
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE2
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
1996-04
|
| Completion Date: |
2001-01
|
| Results First Posted: |
|
| Last Update Posted: |
2005-09-07
|
| Locations: |
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00146484
|
