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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT01954459
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
2. Age 8 years to less than 45 years old.
3. Subject understands the study protocol and agree to comply with it.
4. Subject is on insulin pump or injection-based basal-bolus therapy
5. Subject comprehends written English.
6. For females, subject not intending to become pregnant during the study.
7. Informed Consent Form signed by the subject
8. No history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear.
9. Hemoglobin A1C ≤10%
Exclusion Criteria:
1. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
2. The presence of any of the following diseases:
a. Current use of systemic corticosteroids (within the last week) b. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Current or past use of a continuous glucose sensor is not an exclusion criterion.
5. Active skin condition that would affect sensor placement
6. Use of acetaminophen or Vitamin C supplement within the last 7 days
7. Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
8. Pregnancy A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
44 Years
Study:
NCT01954459
Study Brief:
Protocol Section:
NCT01954459