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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04790760
Eligibility Criteria:
Inclusion Criteria:
* Adult 18-65 years of age
* Diagnosed with type 2 diabetes
* Willing to wear CGM for 6 weeks on both arms
* Willing to come in for 4 office visits over 6 weeks
* Willing to consume assigned supplement twice a day for 4 weeks
* Willing to receive and respond to daily text messages or maintain a daily study log of supplement consumption
* Have active health insurance
* Willing to refrain from any heat therapy for the duration of the study
* Willing to refrain from taking any other supplements that are deemed by the investigator to alter glucose for the duration of the study
* Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to a known interaction with CGMs
* Be able to self-monitor blood glucose with finger-stick method
* Have a baseline HbA1c \> 6.5%
Exclusion Criteria:
* Any active dermatologic condition on the upper arms
* Implanted medical devices (i.e. pacemaker)
* Critically ill or dialysis patients
* Planned magnetic resonance imaging screening, computed tomography scan, x-ray imaging or high-frequency electrical heat treatment during study period
* Current systemic infections
* Participants who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
* Change in diabetic medication regimen within the previous 30 days (except insulin)
* Self-identified allergy to cinnamon or aloe vera
* Refusal to sign the informed consent document
* Pregnant, planned-pregnancy during study period or currently breast-feeding
* History of hypoglycemic episodes warranting medical attention experienced in the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04790760
Study Brief:
Protocol Section:
NCT04790760