Clinical trial NCT05849428: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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).
timeFrame: 14 days
Secondary outcomes:
measure: Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL).
timeFrame: 14 days
measure: Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL).
timeFrame: 14 days
Other outcomes:
Locations:
city: Stockton
country: United States
facility: University of the Pacific
state: California
Study officials:
References:
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.
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.
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.
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.
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.