Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849428
• Other study ID #: IRB2023-25
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: March 2024

Study information

• Verified date: April 2023
• Source: University of the Pacific
• Contact: Sarika Mujumdar, PharmD
• Phone: 209-946-7754
• Email: icor[@]pacific.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of glucose measurement such as consistently measuring on only one side of the body.

Description:

The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:

• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (<70 mg/dL; 70-180 mg/dL; >180 mg/dL)?

Participants will wear two Freestyle Libre 3 sensors, 1 on the left and 1 on the right arm, continuously for 2 weeks. Participants will need to download the Freestyle Libre 3 app on two separate mobile devices and connect the sensors with Freestyle Libre View accounts provided by the study team. The study team will collect and compare the data between the left and right arm for further analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults 18-65 years of age

• Diagnosed with Type 1 or Type 2 Diabetes

• Willing to wear CGMs for 2 weeks on both arms

• Willing to attend 3 virtual calls meetings over the course of the trial

• Have active health insurance

• Willing to refrain from any heat therapy for the duration of the study

• Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs

• Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs

• Not currently using any Freestyle Libre CGM

• Willing to provide HbA1c readings within 3 months of the trial

• Have a baseline HbA1c equal or above 6.5

Exclusion Criteria:

• Any active dermatologic condition on the upper arms

• Implanted medical devices including another continuous glucose monitoring device (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

• Subjects 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

• Refusal to sign the informed consent document

• Pregnant, planned pregnancy during study period, or currently breast-feeding

• Fear of needles to the point where patients cannot self-administer the sensors

• History of allergic reactions or hypersensitivity from adhesives

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• Freestyle Libre 3
Freestyle Libre 3 consists of a sensor that is applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor will continuously read interstitial glucose readings every minute and syncs with the Freestyle View app. At the completion of the study, the sensor is discarded per protocol.

Locations

Country	Name	City	State
United States	University of the Pacific	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-matched CGM-derived blood glucose differences between left arm and right arm in patients with Type 1 or Type 2 Diabetes below target range (<70 mg/dL).	Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis below the target range (<70 mg/dL).	14 days
Secondary	Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL).	Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (70-180 mg/dL).	14 days
Secondary	Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL).	Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (>180180 mg/dL).	14 days

External Links

•   957-P: Differences in Glucose Level between Left Arm and Right Arm Using Continuous Glucose Monitors
•   FreeStyle Libre 2-Best Glucose Monitor For Kids - Coming Soon for Patients 4+. Continuous Glucose Monitoring System.
•   This pilot program as part of Abbott's broader approach to protecting the environment