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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04214704
Eligibility Criteria:
Inclusion Criteria:
1. Less than or equal to 70 years of age. If minor (\<18 years), accompanied by caretaker.
2. Diagnosed with either Type 1 or Type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects
3. Presenting with an uncontrolled glycemic status (HbA1c \>8.0%).
4. Ready for Self-Monitoring of Blood Glucose (SMBG) practices.
5. Attending physician prescribed testing at least 2 times per day
6. Judged by the study trainer to be competent to correctly use Genteel AND demonstrated to the trainer that the subject can use the Genteel device properly.
Exclusion Criteria:
1. More than 70 years and less than 5 years
2. HbA1c \< 8.0%
3. Unwilling for SMBG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
70 Years
Study:
NCT04214704
Study Brief:
Protocol Section:
NCT04214704