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

August 3, 2016 updated by: Kinderkrankenhaus auf der Bult

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30173
        • Kinder - und Jugendkrankenhaus AUF DER BULT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
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
Insulin for beer
Other Names:
  • Novorapid or Humalog
NO_INTERVENTION: Standard
No Insulin Treatment of carbohydrates in beer.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
Time Frame: 18 hours
18 hours
• Total Area under the curve
Time Frame: 18 hours
18 hours
• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
Time Frame: 18 hours
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
18 hours
• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
Time Frame: 18 hours
18 hours
• Time in Hypoglycaemia <70 mg/dl per treatment arm
Time Frame: 18 hours
18 hours
• Max. alcohol in expiratory breath
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinderkrankenhaus auf der Bult

Collaborators

Hannover Medical School

Investigators

  • Principal Investigator: Torben Biester, MD, Study physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (ESTIMATE)

August 7, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEER2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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