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Personalized Fingertip Glucose Measurement With a Touch Sensor

Sponsor
University of California, San Diego (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05315973
Collaborator
(none)
25
Enrollment
1
Arm
13
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Testing sensor vs glucometer
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Personalized Fingertip Glucose Measurement With a Touch Sensor
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sensor group

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

Outcome Measures

Primary Outcome Measures

  1. Accuracy: glucose readings in mg/dL [1 day]

    Correlation of touch sensor glucose readings compared with glucometer measurements

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, San Diego

Investigators

  • Principal Investigator: Edward C Chao, DO, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward Chao, Clinical Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT05315973
Other Study ID Numbers:
  • 801468
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 7, 2022