Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT02881060
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02881060
Study Brief:
Protocol Section:
NCT02881060