How to be Safe With Alcoholic Drinks in Diabetes (BEER)
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|ClinicalTrials.gov Identifier: NCT02518022|
Recruitment Status : Withdrawn (unexpected low willingness of patient to participate on the study)
First Posted : August 7, 2015
Last Update Posted : August 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Hypoglycemia||Drug: Insulin||Not Applicable|
Participants will get two times a height, weight an gender based amount of beer.
One time (Standard) there will be no Insulin given for the beer. Second time (Intervention) half of the carbohydrates containing in the beer will be covered with Insulin, additionally the basal rate will be set to 50% for 12 hours.
All the time, Glucose will be monitored by continuous subcutaneous Glucose Monitoring.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
For carbohydrates in beer, subjects will get covering by Insulin (1/2 of calculated amount). As well Insulin basal rate will set to half for 12 hours
Insulin for beer
Other Name: Novorapid or Humalog
No Intervention: Standard
No Insulin Treatment of carbohydrates in beer.
- • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) [ Time Frame: 18 hours ]
- • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day [ Time Frame: 18 hours ]
- • Total Area under the curve [ Time Frame: 18 hours ]
- • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day [ Time Frame: 18 hours ]
- • Time from end of consumption to nadir of serum glucose
- • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch [ Time Frame: 18 hours ]
- • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch [ Time Frame: 18 hours ]
- • Time in Hypoglycaemia <70 mg/dl per treatment arm [ Time Frame: 18 hours ]
- • Max. alcohol in expiratory breath [ Time Frame: 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518022
|Kinder - und Jugendkrankenhaus AUF DER BULT|
|Hannover, Germany, 30173|
|Principal Investigator:||Torben Biester, MD||Study Physician|