Hypoglycemia, Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition
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.
Interventions
DRUGInsulin
Insulin for beer
Sponsors
Hannover Medical School
Kinderkrankenhaus auf der Bult
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) | 18 hours |
Secondary
| Measure | Time frame |
|---|---|
| • Total Area under the curve | 18 hours |
| • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day | 18 hours |
| • Time from end of consumption to nadir of serum glucose | — |
| • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day | 18 hours |
| • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch | 18 hours |
| • Time in Hypoglycaemia <70 mg/dl per treatment arm | 18 hours |
| • Max. alcohol in expiratory breath | 3 hours |
| • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch | 18 hours |
Countries
Germany
Outcome results
None listed