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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00740012
Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetic patients (diagnosed longer than 2 years)
* HBA1c 5,0 - 9,5 %
* Age 18-75 years
* Hospitalized patients
* Male or female, if female exclusion of pregnancy or secure contraception
* Body-Mass-Index 19-40 kg/m²
* Patient is elucidated
* Patients agreement
Exclusion Criteria:
* Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft
* HbA1c \< 5,0 % or \> 9,5 %
* A severe hypoglycemia with unconsciousness within the last 2 month
* Body-Mass-Index \< 19 or \> 40 kg/m²
* No patient agreement
* Pregnancy (positive pregnancy test) or unsecured contraception.
* Agina pectoris or acute myocardial infarct, as continuous problem
* Inadequate treated arterial hypertension \> 160 mmHg systolic and/or \< 95 mmHg diastolic
* Active tumor disease
* Anemia hemoglobin \< 11,5 g/dl
* Treatment with steroids, sedative or anesthetics
* Infection/fewer \> 37.5 °C
* Renal- malfunction (serum- creatinine \> 1.5 mg/dl)
* Liver- malfunction (GPT and AP \> double of upper- limit)
* Alcohol or drug abuse
* Sleep disorder
* Participation in clinical studies within the last 3 month
* Other significant health dysfunctions, which would affect the outcome of this study
* Incapable to conform the requirements of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00740012
Study Brief:
Protocol Section:
NCT00740012