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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01093833
Eligibility Criteria:
Inclusion Criteria:
* Otherwise healthy male and female subjects with Type 1 or Type 2 diabetes mellitus
* Signed informed consent
* Age between 18 and 65 years, inclusive
* Body mass index between 19 and 30 kg/m², inclusive
* HbA1c \< 11 %
Exclusion Criteria:
* Uncontrolled arterial hypertension (diastolic blood pressure \>90 mm Hg and/or systolic blood pressure \>160 mm Hg)
* Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit
* Impaired renal function measured as creatinine \> 1.2 times above the upper limit of normal.
* Severe acute diseases, i.e. cardiac, pulmonary, gastrointestinal, hepatic, neurologic, or infectious that might interfere with the performance of this study, as judged by the Investigator.
* Severe chronic diseases, as judged by the investigator other than Type 1 Diabetes
* Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
* Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment
* Positive serology for Hepatitis B, Hepatitis C or HIV
* Pregnancy, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
* Known current or recent alcohol or drug abuse
* Blood donation of more than 500 ml within the last three months
* Anticoagulant therapy
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Previous participation in a study involving the GBP-based sensor
* Has taken more than 4000 mg or more of acetaminophen within the past 24 hours (i.e. 13 or more regular strength or 8 or more extra strength Tylenol in the past 24 hours)
* Any skin condition that may be judged to have affect on study ( e.g., bad sunburn, pre-existing dermatitis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01093833
Study Brief:
Protocol Section:
NCT01093833