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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freestyle Libre 3
Sponsored by
University of the Pacific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of the PacificRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Measuring Arm

Arm Description

Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 28, 2023
Last Updated
April 28, 2023
Sponsor
University of the Pacific
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1. Study Identification

Unique Protocol Identification Number
NCT05849428
Brief Title
Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Pacific

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Measuring Arm
Arm Type
Other
Arm Description
Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days).
Intervention Type
Device
Intervention Name(s)
Freestyle Libre 3
Other Intervention Name(s)
Continuous Glucose Monitoring (CGM) device
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL).
Description
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).
Time Frame
14 days
Title
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL).
Description
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).
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarika Mujumdar, PharmD
Phone
209-946-7754
Email
icor@pacific.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Lat, PharmD
Phone
209-946-7754
Email
icor@pacific.edu
Facility Information:
Facility Name
University of the Pacific
City
Stockton
State/Province
California
ZIP/Postal Code
95211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Shah
Email
sshah@pacific.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
19429875
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.
Results Reference
background
PubMed Identifier
28322063
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.
Results Reference
background
PubMed Identifier
28540756
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.
Results Reference
background
PubMed Identifier
31862749
Citation
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.
Results Reference
background
PubMed Identifier
30575414
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.
Results Reference
background
Links:
URL
https://doi.org/10.2337/db19-957-P
Description
957-P: Differences in Glucose Level between Left Arm and Right Arm Using Continuous Glucose Monitors
URL
https://www.freestyle.abbott/us-en/products/freestyle-libre-2.html
Description
FreeStyle Libre 2-Best Glucose Monitor For Kids - Coming Soon for Patients 4+. Continuous Glucose Monitoring System.
URL
https://www.freestyle.abbott/us-en/home/sensor-kit-take-back-pilot.html
Description
This pilot program as part of Abbott's broader approach to protecting the environment

Learn more about this trial

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

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