Glucose Differences Between the Left Arm and Right Arm in Diabetic Patients Using a Continuous Glucose Monitor

NCT04790760 | Unknown FDA Device

• 1 other identifier: 20-29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 therapy by looking at real time glucose levels. While the accuracy of these devices is extensively researched, there are no large-scale studies evaluating the differences between left and right arm glucose readings in the diabetic population. Additionally cinnamon and aloe vera are supplements commonly used by diabetic patients to help improve glycemic control. However, there remains a shortage of studies researching the effects of cinnamon and aloe vera on diabetic patients' glycemic control. The purpose of this study is to determine if there is a difference between glucose levels in the right arm and left arm in diabetic patients and to evaluate if cinnamon and aloe vera supplements impact glycemic control in diabetic patients.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Difference in time-matched glucose levels between the right arm and the left arm

  6 weeks

Secondary Outcomes (3)

• Difference in time in range between the right arm and the left arm

  6 weeks

• Difference in time above range between the right arm and the left arm

  6 weeks

• Difference in time below range between the right arm and the left arm

  6 weeks

Other Outcomes (12)

• Change in continuous glucose monitor measured glucose levels

  6 weeks

• Change in hemoglobin A1c

  6 weeks

• Change in blood pressure

  6 weeks

Study Arms (1)

Continuous Glucose Monitoring

EXPERIMENTAL

Participants will wear a CGM device on the back of both their left and right arm for 6 weeks.

Dietary Supplement: Supplement Consumption; Device: Continuous Glucose Monitors

Interventions

Supplement Consumption DIETARY_SUPPLEMENT

Participants will consume one 500 mg cinnamon capsule and one 300 mg aloe vera capsule twice per day for weeks 3-6.

Continuous Glucose Monitoring

Continuous Glucose Monitors DEVICE

Participants will wear a CGM on the back of their left and right arm for weeks 1-6.

Continuous Glucose Monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Pacific: lead
• Manshadi Heart Institute, Inc.: collaborator

Study Sites (1)

Manshadi Heart Institute, Inc.

Stockton, California, 95204, United States

RECRUITING

Related Publications (9)

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8.

  PMID: 19429875 BACKGROUND

• Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use-guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf. Accessed October 10, 2016.

  BACKGROUND

• Siegmund T, Heinemann L, Kolassa R, Thomas A. Discrepancies Between Blood Glucose and Interstitial Glucose-Technological Artifacts or Physiology: Implications for Selection of the Appropriate Therapeutic Target. J Diabetes Sci Technol. 2017 Jul;11(4):766-772. doi: 10.1177/1932296817699637. Epub 2017 Mar 21.

  PMID: 28322063 BACKGROUND

• Shapiro AR. Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? J Diabetes Sci Technol. 2017 Jul;11(4):833-838. doi: 10.1177/1932296816688303. Epub 2017 Mar 1.

  PMID: 28540756 BACKGROUND

• American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S66-S76. doi: 10.2337/dc20-S006.

  PMID: 31862749 BACKGROUND

• Vigersky RA, McMahon C. The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes. Diabetes Technol Ther. 2019 Feb;21(2):81-85. doi: 10.1089/dia.2018.0310. Epub 2018 Dec 21.

  PMID: 30575414 BACKGROUND

• FreeStyle Libre 2-Best Glucose Monitor For Kids - Coming Soon for Patients 4+. Continuous Glucose Monitoring System. https://www.freestylelibre.us/system-overview/freestyle-libre-2.html. Accessed June 21, 2020.

  BACKGROUND

• Kawatra P, Rajagopalan R. Cinnamon: Mystic powers of a minute ingredient. Pharmacognosy Res. 2015 Jun;7(Suppl 1):S1-6. doi: 10.4103/0974-8490.157990.

  PMID: 26109781 BACKGROUND

• Foster M, Hunter D, Samman S. Evaluation of the Nutritional and Metabolic Effects of Aloe vera. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2011. Chapter 3. Available from: https://www.ncbi.nlm.nih.gov/books/NBK92765/

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sachin Shah, PharmD

  University of the Pacific

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin Shah, PharmD

CONTACT

7074233277; sshah@pacific.edu

Elizabeth Lindemann

CONTACT

7074233277; e_lindemann@u.pacific.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)