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Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10

Unknown status
Clinical Trial NCT05849428 is an interventional study for Type 1 Diabetes, Type 2 Diabetes that is unknown status. It started on 1 May 2023 with plans to enroll 10 participants. Led by University of the Pacific, it is expected to complete by 1 March 2024. The latest data from ClinicalTrials.gov was last updated on 8 May 2023.
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 gluc...Show More
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...

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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

Conditions
Type 1 DiabetesType 2 Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • IRB2023-25
NCT ID Number
NCT05849428
Start Date (Actual)
2023-05
Last Update Posted
2023-05-08
Completion Date (Estimated)
2024-03
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Unknown status
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherMeasuring 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).
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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).
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 MeasureMeasure DescriptionTime Frame
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
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
University of the Pacific logoUniversity of the Pacific
Study Responsible Party
Sachin Shah, Principal Investigator, Professor of Pharmacy, University of the Pacific
Study Central Contact
Contact: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
Contact: Allen Lat, PharmD, 209-946-7754, [email protected]
1 Study Locations in 1 Countries

California

University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, Contact, [email protected]
Recruiting