| Trial ID: | L6115 |
| Source ID: | NCT02518022
|
| Associated Drug: |
Insulin
|
| Title: |
How to be Safe With Alcoholic Drinks in Diabetes
|
| Acronym: |
BEER
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus|Hypoglycemia
|
| Interventions: |
DRUG: Insulin
|
| Outcome Measures: |
Primary: • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am), 18 hours | Secondary: • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day, 18 hours|• Total Area under the curve, 18 hours|• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day, 18 hours|• Time from end of consumption to nadir of serum glucose|• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch, 18 hours|• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch, 18 hours|• Time in Hypoglycaemia <70 mg/dl per treatment arm, 18 hours|• Max. alcohol in expiratory breath, 3 hours
|
| Sponsor/Collaborators: |
Sponsor: Kinderkrankenhaus auf der Bult | Collaborators: Hannover Medical School
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2016-06
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-04
|
| Locations: |
Kinder - und Jugendkrankenhaus AUF DER BULT, Hannover, 30173, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02518022
|
