Recruiting

Observational Study

Sponsor:

University of the Pacific

Code:

NCT05849428

Conditions

Type 1 Diabetes

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Freestyle Libre 3

Study Details

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.

Conditions

Type 1 Diabetes

Type 2 Diabetes

Study ID

NCT05849428

Start date

May, 2023

Status verified date

Apr, 2023

Completion date

Mar, 2024

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Measuring 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).

Interventions

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, the sensor is discarded per protocol.

Primary outcome 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). [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Sarika Mujumdar, PharmD

209-946-7754icor@pacific.edu

Allen Lat, PharmD

209-946-7754icor@pacific.edu

Locations

University of the Pacific

Recruiting

Stockton, California, United States, 95211

Contacts

Sachin Shah

sshah@pacific.edu

More Information

Sponsor

University of the Pacific

Last update posted

May 8, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2023-05-08.