The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes (ALCO1)

This is an interventional treatment trial for Hypoglycemia focused on measuring Glucagon, Ethanol Read More

Inclusion Criteria:

• Age 18 - 70 years
• T1D ≥ 3 year
• BMI 20-28 kg/m2
• CSII ≥ 1 year
• Caucasian origin
• Hypoglycaemia awareness (assessed by Gold, Clarke and Pedersen-Bjergaard methods)
• Use of carbohydrate counting and the insulin pump bolus calculator for all meals
• Ethanol exposure once within 1 year consisting of at least 4 drinks (1 drink contains 12 gram ethanol) within four hours

Exclusion Criteria:

• Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
• Allergy for ethanol or any food ingredients that will be used in the study.
• Impaired renal function (eGFR < 60 ml/min/1.73m2)
• Liver disease with ALAT > 2.5 times the upper limit of the reference interval
• Gastropareses (beat-beat variation < 10 beats per min and/or orthostatic systolic blood pressure > 20 mmHg)
• Insomnia, sleep apnoea or any troubles with sleeping that according to the investigator's assessment makes the individual unsuitable for study participation.
• Aldehyde dehydrogenase deficiency as determined by a screening questionnaire
• Unable to refrain from the consumption of ethanol at least 24 hours prior to study start
• History of drinking problems or alcoholism, regardless of whether active or in remission.
• Use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness
• History of drug abuse
• Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject.
• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
• Use of medications that are known to cause QT interval prolongation
• Presence of pheochromocytoma
• Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
• Females who have different basal insulin pattern depending on their menstrual cycle.
• Inability to understand the individual information and to give informed consent.