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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT04604093
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be at least 18 years of age.
2. Subject must have HbA1c of \> 7.5% at screening
3. Subject has 35% or more time spent above 180 mg/dL during the screening phase.
4. Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment.
5. Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes.
6. Subject must be on at least one (1) oral anti-diabetes medication.
7. Subject must be able to read and understand English.
8. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
9. Subject is willing to make diet and lifestyle changes in response to education and glucose data
10. Subject must be available to participate in all study visits.
11. Subject must be willing and able to provide written signed and dated informed consent.
Exclusion Criteria:
1. Subject is currently on any form of insulin therapy.
2. Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment.
3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
4. Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
5. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
6. Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
7. Subject is currently undergoing dialysis and/or has end stage renal disease.
8. Subject is currently participating in another interventional clinical trial.
9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04604093
Study Brief:
Protocol Section:
NCT04604093