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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT01216618
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18- 65 years old (including = 18 years and =65 years)
2. Gender: men and women
3. BMI: 18-35 kg/m2
4. Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
5. Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
6. Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
7. Subject is 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), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
5. Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
6. Suffer from uncontrolled Hypertension (blood pressure in mm HG \>160 systolic or \> 95 diastolic)
7. Low blood hemoglobin concentration \<9 g/dL for female and \<11g/dL for male.
8. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
9. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH\>5.5 mIU/L or TSH\<0.4 mIU/L
10. Psychological incompetence
11. Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
12. Subjects with diminished skin integrity
13. Subjects with heat sensitivity
14. Subjects involved in or planed to participate in other studies
15. Subjects using other drugs therapies to control blood glucose level other than insulin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01216618
Study Brief:
Protocol Section:
NCT01216618