Personalized Fingertip Glucose Measurement With a Touch Sensor

NCT05315973 | Withdrawn

• 1 other identifier: 801468
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Accuracy: glucose readings in mg/dL

  Correlation of touch sensor glucose readings compared with glucometer measurements

  1 day

Secondary Outcomes (1)

• Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest

  1 day

Study Arms (1)

Sensor group

EXPERIMENTAL

Device: Testing sensor vs glucometer

Interventions

Testing sensor vs glucometer DEVICE

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

Sensor group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Edward C Chao, DO

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 7, 2022
• Study Start: June 1, 2022
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: approximately 10 yrs