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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04621656
Eligibility Criteria:
Inclusion Criteria:
* Healthy, have pre-diabetes or metabolic syndrome or type 2 diabetes on metformin or GLP-1 or SGLT-2 therapy
* Have access to smart-phone with NFC reader
* Be willing to wear a continuous glucose monitor (CGM) and a smartwatch 24 hours/day for 10-14 consecutive days at a time
* Be willing to limit swimming to a maximum of 30 minutes per session while wearing CGM
* Available for two in-person or remote study visits (study orientation and close-out)
* Willing to provide weight at baseline and comprehensive logging of their activity, food and water consumption for 10-14 days
* Covered by health insurance plan
* Able and willing to give informed consent for study participation
Exclusion Criteria:
* Use of vitamin C supplements in excess of 200% of the United States Recommended Daily Allowance at least 14 days prior to starting the trial
* Allergy to skin adhesives used in the trial
* Women who are pregnant, lactating, have given birth in the past 6 months, or are planning to get pregnant in the next 6 months
* Individuals deemed unfit for participation by study physician
* Allergy to nuts
* Individuals who are taking any of the following medications:
* Insulin
* Progesterone
* Atypical antipsychotics
* Oral or injectable antidiabetic medications EXCEPT for metformin or Glucagon-like peptide-1 (GLP-1) agonists or Selective sodium-glucose transporter-2 (SGLT-2) inhibitors
* Oral corticosteroid use
* Triphasic oral contraceptives
* Blood thinners
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04621656
Study Brief:
Protocol Section:
NCT04621656