Personalized Fingertip Glucose Measurement With a Touch Sensor

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus
• Interventions: Device: Testing sensor vs glucometer

• Registration Number: NCT05315973
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-07
• Study Start: 2022-06-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sensor group	Testing sensor vs glucometer	-

Primary Outcome Measures

Name	Time	Method
Accuracy: glucose readings in mg/dL	1 day	Correlation of touch sensor glucose readings compared with glucometer measurements

Secondary Outcome Measures

Name	Time	Method
Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest	1 day	ease of use, and any other comments to optimize the design and function of this sensor, as reported by the participants