- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02881060
The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes (ALCO1)
Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing hypoglycaemia.
The purpose of this study is to determine, whether ethanol influences the glucose response to subcutaneous glucagon during mild hypoglycaemia.
The investigators hypothesize that prior evening ethanol consumption does not reduce the effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol consumption.
The study aims:
- To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia.
- To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia
A double-blinded placebo-controlled study will be conducted. Participants will serve as their own controls. Eligible participants will after an informed consent complete two study visits, one with and one without ethanol consumption, in a random order. On each study visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100 mcg glucagon is administered. Two hours later a second bolus is administered.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Hvidovre, 덴마크, 2650
- Hvidovre University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Ethanol
Drinking a cocktail of ethanol (0.8 g ethanol per kg body weight), diet lemonade and water of 1:1:1 (volume distribution).
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다른 이름들:
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위약 비교기: Non-ethanol
Drinking a cocktail of diet lemonade and water of 1:2 (volume distribution).
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Increase in plasma glucose
기간: 0-120 min after the first glucagon injection
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The primary endpoint is difference in increase in plasma glucose value after the first injection of 100 µg s.c.
glucagon on study nights with ethanol vs. study nights without ethanol consumption.
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0-120 min after the first glucagon injection
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Peak plasma glucose
기간: 0-240 min after the first glucagon injection
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Maximal plasma glucose after the first and second glucagon injection
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0-240 min after the first glucagon injection
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Increase in plasma glucose
기간: 0-120 min after the second glucagon injection
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Increase in plasma glucose caused by the second glucagon injection.
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0-120 min after the second glucagon injection
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Total AUC(0-120)
기간: 0-240 min after the first glucagon injection
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Total area under the glucose curve from 0-120 minutes after each glucagon injection
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0-240 min after the first glucagon injection
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PI-AUC(0-120)
기간: 0-240 min after the first glucagon injection
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positive incremental area under the glucose curve from 0-120 minutes after each glucagon injection
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0-240 min after the first glucagon injection
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Tmax
기간: 0-240 min after the first glucagon injection
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Time-to-peak glucose value after each glucagon injection glucagon injection
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0-240 min after the first glucagon injection
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Time above 4.0mM
기간: 0-240 min after the first glucagon injection
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Duration of glucose above 4.0 mmol/l after first and second glucagon injection
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0-240 min after the first glucagon injection
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Time above baseline
기간: 0-240 min after the first glucagon injection
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Duration of glucose above baseline after first and second glucagon injection
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0-240 min after the first glucagon injection
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Rescue rates
기간: 0-240 min after the first glucagon injection
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Numbers of first and second glucagon injections that raises PG > 4.9 mmol/l
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0-240 min after the first glucagon injection
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Hyperglycemia rates
기간: 0-240 min after the first glucagon injection
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Number of first and second glucagon injections that raises PG > 7.1 mmol/l
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0-240 min after the first glucagon injection
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Changes in plasma ketone bodies, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in plasma ketone bodies, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in plasma glucagon, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in plasma glucagon, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in insulin, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in insulin, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in growth hormones, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in growth hormones, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in serum corticole, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in serum corticole, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in plasma ethanol, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in plasma ethanol, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in free fatty acids, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in free fatty acids, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in triglycerides, measured as area under the curve
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Changes in triglycerides, measured as incremental peak
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Average in blood pressure
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Average heart rate
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Intensity of hypoglycemia
기간: 0-240 min after the first glucagon injection
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Average changes in Edinburgh Hypoglycaemia Scale over time during insulin and glucagon phase
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0-240 min after the first glucagon injection
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Cognitive impairment
기간: 0-240 min after the first glucagon injection
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Average scores in cognitive test 30 min before each glucagon injection.
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0-240 min after the first glucagon injection
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Side effects
기간: 0-240 min after the first glucagon injection
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Average visual analogue scale score from 0-180 min for nausea and headache after glucagon injection
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0-240 min after the first glucagon injection
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Incidence of vomiting
기간: 0-240 min after the first glucagon injection
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Incidence of vomiting after 0-4 hours after each glucagon injection.
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0-240 min after the first glucagon injection
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Meal induced glucose excursion
기간: 0-3 hours after meal
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Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal
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0-3 hours after meal
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Meal induced hormonal changes
기간: 0-3 hours after meal
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Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal
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0-3 hours after meal
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Nocturnal changes in plasma glucose
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Nocturnal changes in corticol
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Nocturnal changes in growth hormone
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Nocturnal changes in ketones
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Nocturnal changes in ethanol
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Nocturnal changes in glucagon
기간: 0-6 hours after start of sleep
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Area under the curve during sleep
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0-6 hours after start of sleep
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Difference between the first second glucagon injection and between both study visits in peak change plasma glucose
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference between glucagon injections on both study visits in positive incremental area under the glucose curve from 0-120 minutes
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference between glucagon injections on both study visits in total area under the glucose curve from 0-120 minutes
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference between glucagon injections on both study visits in time-to-peak glucose value
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference between glucagon injections on both study visits in duration of glucose above 4.0 mmol/l after first and second glucagon injection
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference between glucagon injections on both study visits in duration of glucose above baseline after first and second glucagon injection
기간: 0-240 min after the first glucagon injection
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0-240 min after the first glucagon injection
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Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Mean absolute relative difference (MARD) values of glucose sensors compared with YSI from 7 PM- 8 AM.
기간: 0-10 hours after meal
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Intentions to treat analysis
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0-10 hours after meal
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Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Precision absolute relative difference (PARD) 120 min before and 120 after each glucagon injection.
기간: 0-10 hours after meal
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Intentions to treat analysis
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0-10 hours after meal
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Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - MARD values between glucose sensors 0-120 minutes after each glucagon injection.
기간: 0-10 hours after meal
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Intentions to treat analysis
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0-10 hours after meal
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Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in range (glucose sensor value =4.0-10.0mmol/l)
기간: 0-2 days after the first glucagon injection
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Intentions to treat analysis
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0-2 days after the first glucagon injection
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Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hypoglycaemia (glucose sensor value < 4.0 mmol/l)
기간: 0-2 days after the first glucagon injection
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Intentions to treat analysis
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0-2 days after the first glucagon injection
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Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hyperglycaemia (glucose sensor value >10.0mmol/l)
기간: 0-2 days after the first glucagon injection
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Intentions to treat analysis
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0-2 days after the first glucagon injection
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Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)
기간: 0-2 days after the first glucagon injection
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Intentions to treat analysis
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0-2 days after the first glucagon injection
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Difference in glucose sensor data between the study period with and without alcohol - Clarke- Error Grid analysis for both sensors compared with YSI during study visit
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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Difference in glucose sensor data between the study period with and without alcohol - PARD values from day 1-7
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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Difference in glucose sensor data between the study period with and without alcohol - PARD values <4.0 mmol/L from day 1-7
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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Difference in glucose sensor data between the study period with and without alcohol - PARD values 4.0-10.0 mmol/L from day 1-7
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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Difference in glucose sensor data between the study period with and without alcohol PARD values >10.0 mmol/L from day 1-7
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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Difference in glucose sensor data between the study period with and without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)
기간: -2 to 4 days after study visits
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Intentions to treat analysis
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-2 to 4 days after study visits
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ajenthen Ranjan, MD, Hvidovre University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
위약에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로