How to be Safe With Alcoholic Drinks in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Insulin for beer

Standard

No Insulin Treatment of carbohydrates in beer.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin

Insulin for beer

Intervention Type DRUG

Other Intervention Names

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Novorapid or Humalog

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No