How to be Safe With Alcoholic Drinks in Diabetes

Kinderkrankenhaus auf der Bult

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Type 1 Diabetes Mellitus Hypoglycemia

Interventions

InsulinDRUG

Insulin for beer

Eligibility

Sex: ALLMin age: 16 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, Germany

Outcomes

Primary Outcomes

• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)

Time frame: 18 hours

Secondary Outcomes

• 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

Data from ClinicalTrials.gov

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