Type 1 Diabetes, Type 2 Diabetes
Conditions
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.
Interventions
DEVICEFreestyle 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.
Sponsors
University of the Pacific
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL). | 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). |
| Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL). | 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). |
Countries
United States
Contacts
Primary ContactSarika Mujumdar, PharmD
Backup ContactAllen Lat, PharmD
Outcome results
None listed