How to be Safe With Alcoholic Drinks in Diabetes (BEER)

Children's Hospital Auf der Bult

Status: Withdrawn

Conditions: Hypoglycemia; Type 1 Diabetes Mellitus

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02518022

BEER2015

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Insulin

Standard

No Intervention group

Description:

No Insulin Treatment of carbohydrates in beer.