Clinical trial NCT02518022: How to be Safe With Alcoholic Drinks in Diabetes
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Hypoglycemia
Keywords: Type 1 Diabetes mellitus
Hypoglycemia
continuous subcutaneous insulin infusion
Alcohol
continuous glucose monitoring system
Nutrition
Lead sponsor: Kinderkrankenhaus auf der Bult
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2015-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)
timeFrame: 18 hours
Secondary outcomes:
measure: • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
timeFrame: 18 hours
measure: • Total Area under the curve
timeFrame: 18 hours
measure: • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
timeFrame: 18 hours
measure: • Time from end of consumption to nadir of serum glucose
measure: • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch
timeFrame: 18 hours
measure: • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
timeFrame: 18 hours
measure: • Time in Hypoglycaemia <70 mg/dl per treatment arm
timeFrame: 18 hours
measure: • Max. alcohol in expiratory breath
timeFrame: 3 hours
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Kinder - und Jugendkrankenhaus AUF DER BULT
Study officials:
affiliation: Study Physician
name: Torben Biester, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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
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.
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.