Diabetes MellitusNCT05315973
Personalized Fingertip Glucose Measurement With a Touch Sensor
A study testing Testing sensor vs glucometer in people with Diabetes Mellitus, run by University of California, San Diego.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Testing sensor vs glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Testing sensor vs glucometer
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing sensor vs glucometerDevice
Will test accuracy of this sensor; there will be no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Sensor group | Experimental | Not described Receives: Device: Testing sensor vs glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy: glucose readings in mg/dL
Correlation of touch sensor glucose readings compared with glucometer measurements
Measured: 1 day
Secondary outcomes (1)
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2022
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Why it stopped: We never were able to start this study, as an NDA agreement had been signed, after we had anticipated enrolling, preventing starting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Chao, University of California, San Diego
- Investigators
- Edward C Chao, DO, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315973
- Sponsor's protocol ID
- 801468
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will include all data collected in the study, sensor glucose readings, as well as glucometer measurements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Fingertip Glucose Measurement With a Touch Sensor
- ClinicalTrials.gov ID
- NCT05315973
- Acronym / sponsor ID
- 801468
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We never were able to start this study, as an NDA agreement had been signed, after we had anticipated enrolling, preventing starting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensor group | Experimental | Device: Testing sensor vs glucometer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing sensor vs glucometerWill test accuracy of this sensor; there will be no intervention. | Device | Sensor group |
Primary outcome
Accuracy: glucose readings in mg/dL
Time frame: 1 day
Correlation of touch sensor glucose readings compared with glucometer measurements
1 secondary outcome
Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Yes. This will include all data collected in the study, sensor glucose readings, as well as glucometer measurements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward C Chao, DO principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A study testing Testing sensor vs glucometer in people with Diabetes Mellitus, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy: glucose readings in mg/dL (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.