NCT05849428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 8, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 28, 2023

Last Update Submit

April 28, 2023

Conditions

Type 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in 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).

    14 days

Study Arms (1)

Measuring Arm

OTHER

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

Interventions

Freestyle Libre 3DEVICE

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.

Also known as: Continuous Glucose Monitoring (CGM) device
Measuring Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Pacific

Stockton, California, 95211, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 19429875BACKGROUND

  • 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.

    PMID: 28322063BACKGROUND

  • 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.

    PMID: 28540756BACKGROUND

  • 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.

    PMID: 31862749BACKGROUND

  • 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.

    PMID: 30575414BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Central Study Contacts

Sarika Mujumdar, PharmD

CONTACT

209-946-7754icor@pacific.edu

Allen Lat, PharmD

CONTACT

209-946-7754icor@pacific.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 8, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

March 1, 2024

Last Updated

May 8, 2023

Record last verified: 2023-04

Locations

US(1)