| Trial ID: | L3728 |
| Source ID: | NCT02546401
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
|
| Acronym: |
BOLUS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 1
|
| Interventions: |
DRUG: Insulin Aspart
|
| Outcome Measures: |
Primary: Area Under Curve (AUC) of glycemia, Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia), During 14 days | Secondary: Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability, During 14 days|Area Under Curve (AUC) during 4H after a high-fat meal, 4 hours
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Brest
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2016-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-22
|
| Locations: |
CHRU Brest, Brest, 29200, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02546401
|
