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

Primary Purpose

Type 1 Diabetes Mellitus, Hypoglycemia

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Insulin
Sponsored by
Kinderkrankenhaus auf der Bult
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Kinder - und Jugendkrankenhaus AUF DER BULT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard

Arm 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

No Insulin Treatment of carbohydrates in beer.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
• Total Area under the curve
• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
• Time from end of consumption to nadir of serum glucose
• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch
• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
• Time in Hypoglycaemia <70 mg/dl per treatment arm
• Max. alcohol in expiratory breath

Full Information

First Posted
May 22, 2015
Last Updated
August 3, 2016
Sponsor
Kinderkrankenhaus auf der Bult
Collaborators
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02518022
Brief Title
How to be Safe With Alcoholic Drinks in Diabetes
Acronym
BEER
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
unexpected low willingness of patient to participate on the study
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinderkrankenhaus auf der Bult
Collaborators
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Hypoglycemia
Keywords
Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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
Arm Title
Standard
Arm Type
No Intervention
Arm Description
No Insulin Treatment of carbohydrates in beer.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Novorapid or Humalog
Intervention Description
Insulin for beer
Primary Outcome Measure Information:
Title
• 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 Outcome Measure Information:
Title
• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
Time Frame
18 hours
Title
• Total Area under the curve
Time Frame
18 hours
Title
• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
Time Frame
18 hours
Title
• Time from end of consumption to nadir of serum glucose
Title
• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch
Time Frame
18 hours
Title
• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
Time Frame
18 hours
Title
• Time in Hypoglycaemia <70 mg/dl per treatment arm
Time Frame
18 hours
Title
• Max. alcohol in expiratory breath
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Biester, MD
Organizational Affiliation
Study Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinder - und Jugendkrankenhaus AUF DER BULT
City
Hannover
ZIP/Postal Code
30173
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
5774487
Citation
Krebs HA, Freedland RA, Hems R, Stubbs M. Inhibition of hepatic gluconeogenesis by ethanol. Biochem J. 1969 Mar;112(1):117-24. doi: 10.1042/bj1120117.
Results Reference
background
PubMed Identifier
11679452
Citation
Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. doi: 10.2337/diacare.24.11.1888.
Results Reference
background
PubMed Identifier
1499475
Citation
Gin H, Morlat P, Ragnaud JM, Aubertin J. Short-term effect of red wine (consumed during meals) on insulin requirement and glucose tolerance in diabetic patients. Diabetes Care. 1992 Apr;15(4):546-8. doi: 10.2337/diacare.15.4.546.
Results Reference
background
Citation
Jennifer F. Scheel, Karin Schielke, Stefan Lautenbacher, Sabine Aust1, Simone Kremer, Jörg Wolstein; Low-Dose Alcohol Effects on Attention in Adolescents, Zeitschrift für Neuropsychologie, 24 (2), 2013, 103 - 111
Results Reference
background
PubMed Identifier
8299457
Citation
Koivisto VA, Tulokas S, Toivonen M, Haapa E, Pelkonen R. Alcohol with a meal has no adverse effects on postprandial glucose homeostasis in diabetic patients. Diabetes Care. 1993 Dec;16(12):1612-4. doi: 10.2337/diacare.16.12.1612.
Results Reference
background
PubMed Identifier
11197633
Citation
Seidl S, Jensen U, Alt A. The calculation of blood ethanol concentrations in males and females. Int J Legal Med. 2000;114(1-2):71-7. doi: 10.1007/s004140000154.
Results Reference
background

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How to be Safe With Alcoholic Drinks in Diabetes

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