How to be Safe With Alcoholic Drinks in Diabetes

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinderkrankenhaus auf der Bult
• Collaborator: Hannover Medical School
• Treatments: Insulin; Insulin Aspart; Insulin Lispro; Insulin, Globin Zinc

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