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:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT01114061
Eligibility Criteria:
Inclusion Criteria:
1. Participant age between 18- 65 years old (including = 18 years and =65 years)
2. BMI: 18-35 kg/m2
3. Insulin dependent diabetes under insulin pumps.
4. Use of short-acting insulin analogues
5. Subjects agreeing to use the InsuPatch device.
6. 6% ≤ HbA1c ≤ 9.5%
7. Agree to sign consent form.
8. Subject is willing to do at least 4 blood glucose recordings per day
9. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
10. Willing to comply with all specified follow-up evaluations
Exclusion Criteria:
1. Pregnancy
2. Breast feeding women.
3. Alcohol addiction
4. Had CABG (Coronary Artery Bypass Graft), Post MI (Myocardial Infarction) or had active Ischemic heart disease in the last 3 months prior to the study date
5. Had CVA (cardiovascular accident) or TIA (transient ischemic accident) in the last 12 months prior to the study
6. Suffer from Hypertension (blood pressure \> 140/90) .
7. Low blood hemoglobin concentration \<9 g/dL for female and \<11g/dL for male.
8. Known gastro- or enteroparesis
9. Abnormal kidney and/ or liver function tests. (Creatinine \>1.5 mg/dL, liver test\> 2 times the upper limit of the normal range).
10. Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last six months prior to study inclusion
11. Hypoglycaemia unawareness
12. Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion
13. Psychological incompetence
14. Signs of drug abuse
15. Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
16. Not willing to sign the inform consent form.
17. Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites
18. Subjects with heat sensitivity
19. Subjects involved in or planed to participate in other studies.
20. Any subject whom the primary researcher consider not suited to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01114061
Study Brief:
Protocol Section:
NCT01114061