Status:
UNKNOWN
Glucose Differences Between the Left Arm and Right Arm in Diabetic Patients Using a Continuous Glucose Monitor
Lead Sponsor:
University of the Pacific
Collaborating Sponsors:
Manshadi Heart Institute, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Continuous glucose monitoring (CGM) is an emerging field for diabetes management. CGMs are small devices primarily placed on a patient's upper arm that allow providers and patients to individualize th...
Detailed Description
Continuous glucose monitoring (CGM) is an emerging field for diabetes management. CGMs allow providers to individualize therapy by looking at real time glucose levels, detect changes in glucose and ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04790760
Start Date
March 1 2021
End Date
February 1 2022
Last Update
March 10 2021
Active Locations (1)
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1
Manshadi Heart Institute, Inc.
Stockton, California, United States, 95204