| Trial ID: | L5905 |
| Source ID: | NCT05768191
|
| Associated Drug: |
Premix Insulin Human Isophane Suspension And Insulin Human
|
| Title: |
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: premix insulin human isophane suspension and insulin human|DRUG: Humulin N plus Humulin R
|
| Outcome Measures: |
Primary: To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin, 12 months | Secondary: frequency of hypo events (throughout the trial), weekly frequency of hypo events and time below range, 8 months|Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.), The PedsQL 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years and 32 items for ages 2-7 years. Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problems, 8 months|correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32), 8 months
|
| Sponsor/Collaborators: |
Sponsor: Université NAZI BONI | Collaborators: Juvenile Diabetes Research Foundation|International Society for Pediatric and Adolescent Diabetes|Société de Médecine Interne du Burkina Faso|Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-06-15
|
| Completion Date: |
2024-05-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-12
|
| Locations: |
CHU Souro Sanou, Bobo-Dioulasso, Houet, Burkina Faso|CHU de Tengandogo, Ouagadougou, Kadiogo, Burkina Faso|CHU Yalgado Ouedraogo, Ouagadougou, Kadiogo, Burkina Faso
|
| URL: |
https://clinicaltrials.gov/show/NCT05768191
|
