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

University of the Pacific

Status

Enrolling

Conditions

Type 1 Diabetes

Type 2 Diabetes

Treatments

Device: Freestyle Libre 3

Study type

Interventional

Funder types

Other

Identifiers

NCT05849428

IRB2023-25

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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