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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT04651816
Eligibility Criteria:
Inclusion Criteria:
1. Be at least 18 years old and under age 65 AND
2. Body Mass Index ≥25 kg/m2 (≥23 kg/m2 if Asian) AND
3. Not be pregnant at time of enrollment AND
4. Have no previous diagnosis of type 1 or type 2 diabetes AND
5. Have a blood test result in the prediabetes range within the past year, meeting one of these specifications:
1. Hemoglobin A1c: 5.7-6.4%, OR
2. Fasting plasma glucose : 100-125 mg/dL, OR
3. Two-hour plasma glucose (after a 75-gm glucose load): 140-199 mg/dL, OR
4. Have a previous clinical diagnosis of gestational diabetes mellitus (GDM), AND
6. Not in hypertensive crisis with systolic over 180 and/or diastolic over 120
7. Be an established patient at a Penn State Health clinic in State College, PA (i.e. have at least one visit in past 18 months) AND
8. Fluent in English AND
9. Own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours
10. Internet access
11. Tablet or desktop/laptop computer with webcam for classes
12. Active email address
Exclusion Criteria:
1. Under 18 years old and over age 65
2. Body Mass Index \<25 kg/m2 (\<23 kg/m2 if Asian)
3. Pregnant at the time of enrollment
4. Previous diagnosis of type 1 or type 2 diabetes
5. Have a blood test result within the past year meeting one of these specifications:
1. Hemoglobin A1c: not in range of 5.7-6.4%
2. Fasting plasma glucose: not in range of 100-125 mg/dL
3. Two-hour plasma glucose (after a 75-gm glucose load): not in range of 140-199 mg/dL
4. No previous clinical diagnosis of gestational diabetes
6. Active hypertensive crisis with systolic over 180 and/or diastolic over 120 (patients in this category would be referred to primary care provider for immediate visit)
7. Not be an established patient at a Penn State Health clinic in State College, PA (i.e. have not had at least one visit in the past 18 months)
8. Not fluent in English
9. Not own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.
10. Decisional impairment
11. Prisoner status
12. Actively taking any of the following drug classes: Biguanides, Sulfonylureas (SU), Thiazolidendiones (TZD), Meglitinides, Alpha-glucosidase inhibitors, Dipetidyl Peptidase-IV (DPP4) inhibitors, Insulin , Sodiumglucose transporter 2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) .
13. Anyone who does not have internet access
14. Anyone who does not have tablet or desktop/laptop computer with webcam
15. Anyone who does not have an active email address
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04651816
Study Brief:
Protocol Section:
NCT04651816