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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01352767
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged 18 to 70 years (values included)
* Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
* 6% ≤ HbA1c ≤ 9.5%
* Use of short-acting prandial insulin analogues with injections
* Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
* Willing to sign informed consent
Exclusion Criteria:
* Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
* Known gastro- or enteroparesis.
* Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
* Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
* Hypoglycaemia unawareness (Score \> 4 in the Hypoglycaemia Awareness Questionnaire, see appendix)
* Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
* Any known life-threatening disease
* Pregnant women, lactating women or women who intend to become pregnant during the observation period
* Any other condition or compliance issues that might interfere with study participation or results
* Subjects with heat sensitivity
* Subjects involved in or planed to participate in other studies
* Subjects who are incapable of contracting or under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01352767
Study Brief:
Protocol Section:
NCT01352767