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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03577158
Eligibility Criteria:
Inclusion Criteria:
* Age between 18-65 years.
* Under CSII treatment for at least six months before visit 1.
* Body mass index between 18 and 30 kg/m2.
* HbA1c 6.0-8.5% at visit 1.
* Physical examination, laboratory data and EKG without alterations. Abnormalities considered clinically irrelevant by the investigator will not be exclusion criteria.
* Postmenopausal women or women of childbearing age using contraceptives of proven effectiveness and with negative urine pregnancy test at screening visit.
Exclusion Criteria:
* Pregnancy and breastfeeding.
* Hypoglycemia unawareness (Clarke Test \>3).
* Progressive fatal disease.
* History of drug or alcohol abuse.
* History HIV positive, active hepatitis B or hepatitis C.
* Impaired liver function, as shown in, but not limited to, SGPT (serum gutamate pyruvate transaminase) or SGOT (serum glutamate oxaloacetate transaminase) more than twice the upper limit of normal at Visit 1.
* Clinically relevant microvascular complications (macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine or other systematic, apart from T1D, which may hamper the implementation of the clinical study protocol or interpretation of results study.
* Scheduled surgery during the study period.
* Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
* Subjects those are unlikely to meet the clinical study protocol, eg uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
* Using an experimental drug or device during the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03577158
Study Brief:
Protocol Section:
NCT03577158