How to be Safe With Alcoholic Drinks in Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Type 1 Diabetes Mellitus, Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by participants Signed informed consent by parent or legal guardian of adolescent participants <18 years of age Age between16-21 years (both including) >1 year Type 1 Diabetes continuous subcutaneous insulin infusion for at least 3 months HbA1c 7-10 % (both including) BMI between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults Ability to wear glucose sensor Normal liver enzymes (alanine aminotransferase , aspartate transaminase , Gamma-Glutamyl-Transferase, bilirubin) in age appropriate range by local lab Exclusion Criteria: Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month Alcohol or drug abuse Psychiatric disorder Unstable other metabolic disease as judged by investigator Intake of glucocorticoids or growth hormone Allergy to adhesive Coeliac disease Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Drug: Insulin<br>* Insulin for beer<br>* Other names: Novorapid or Humalog;|
| No Intervention: Standard<br>No Insulin Treatment of carbohydrates in beer. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) |  | 18 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition