Personalized Fingertip Glucose Measurement With a Touch Sensor

Diabetes Mellitus Clinical Trial

Official title:

Personalized Fingertip Glucose Measurement With a Touch Sensor

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05315973
• Other study ID #: 801468
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Testing sensor vs glucometer
Will test accuracy of this sensor; there will be no intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy: glucose readings in mg/dL	Correlation of touch sensor glucose readings compared with glucometer measurements	1 day
Secondary	Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest	ease of use, and any other comments to optimize the design and function of this sensor, as reported by the participants	1 day