Personalized Fingertip Glucose Measurement With a Touch Sensor

NCT ID: NCT05315973

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-27

Brief Summary

Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which causes discomfort or inconvenience eventually lead to decreased willingness to perform such needle-based check-ups that are vital to DM management. While technology has evolved, currently there is no glucose monitoring device that is needle-free. The investigators are studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's fingertip. As it has not yet been tested in individuals with DM, the team will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive glucose sensor.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sensor group

Group Type: EXPERIMENTAL

Testing sensor vs glucometer

Intervention Type: DEVICE

Will test accuracy of this sensor; there will be no intervention.

Interventions

Testing sensor vs glucometer

Will test accuracy of this sensor; there will be no intervention.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes
• Having a hemoglobin A1c < 9.0%, and taking medication for diabetes. Individuals will bring their own lab report.
• Ability to provide informed consent for participation.

Exclusion Criteria

• Individuals without diabetes
• Uncontrolled medical conditions, including diabetes with a hemoglobin A1c > 9.0%, hypertension, heart, kidney, or liver failure.
• Those who cannot speak or read English. Participation will be limited to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating.
• Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Edward Chao

Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward C Chao, DO

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Other Identifiers

801468

Identifier Type: -

Identifier Source: org_study_id