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

April 28, 2023 updated by: Sachin Shah, University of the Pacific

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarika Mujumdar, PharmD
  • Phone Number: 209-946-7754
  • Email: icor@pacific.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Stockton, California, United States, 95211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Measuring Arm
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).
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.
Other Names:
  • Continuous Glucose Monitoring (CGM) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL).
Time Frame: 14 days
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
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL).
Time Frame: 14 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Pacific

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023-25

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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