Diabetes MellitusNCT04088201
Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
A study testing Glucose measurements in people with Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
Trial summary
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which can cause discomfort or inconvenience; these and other factors can lead to decreased willingness to perform these checks 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?
- Glucose measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to Jun 2021
- 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
- Ability to provide informed consent for participation.
Who cannot join
- Individuals without diabetes
- Those who cannot speak or read English. We are limiting participation 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92037
Carolyn Hernandez, BA, 858-246-5145, jhmills@ucsd.edu
Edward Chao, DO, 619-400-5050 ext. Chao, ecchao@ucsd.edu
About this study
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which can cause discomfort or inconvenience; these and other factors can lead to decreased willingness to perform these checks that are vital to DM management. While technology has evolved, a needle-free glucose monitoring device is currently not available. The investigators are studying a glucose sensor that adheres to the skin, similarly to a temporary tattoo. This sensor can now obtain continuous readings. As it has not yet been tested in individuals with DM, this study 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, wearable glucose sensor that can provide measurements of glucose levels continuously.
- Conditions
- Diabetes Mellitus
- Being tested
- Glucose measurements
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose measurementsDevice
We will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer.
| Study group | Role | What they receive |
|---|---|---|
| Measuring glucose | Experimental | Measuring glucose from interstitial fluid Receives: Device: Glucose measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial fluid glucose readings
Needle-less measurements with an epidermal sensor - pls note, study is to assess how sensor readings compare with those from a glucometer
Measured: Hourly, up to 8 hours
Secondary outcomes (1)
Acceptablility of sensor
Will survey pts
Measured: At end of study testing sessions, at 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start26 Sep 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088201
- Sponsor's protocol ID
- 190708
- Status last verified
- Jul 2020
- First submitted
- 9 Sep 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
- ClinicalTrials.gov ID
- NCT04088201
- Acronym / sponsor ID
- 190708
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 Sep 2019 (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 can cause discomfort or inconvenience; these and other factors can lead to decreased willingness to perform these checks that are vital to DM management. While technology has evolved, a needle-free glucose monitoring device is currently not available. The investigators are studying a glucose sensor that adheres to the skin, similarly to a temporary tattoo. This sensor can now obtain continuous readings. As it has not yet been tested in individuals with DM, this study 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, wearable glucose sensor that can provide measurements of glucose levels continuously.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measuring glucose | Experimental | Device: Glucose measurementsMeasuring glucose from interstitial fluid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes
- Ability to provide informed consent for participation.
Key exclusion criteria (3 listed)
- Individuals without diabetes
- Those who cannot speak or read English. We are limiting participation 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 |
|---|---|---|
| Glucose measurementsWe will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer. | Device | Measuring glucose |
Primary outcome
Interstitial fluid glucose readings
Time frame: Hourly, up to 8 hours
Needle-less measurements with an epidermal sensor - pls note, study is to assess how sensor readings compare with those from a glucometer
1 secondary outcome
Acceptablility of sensor
Time frame: At end of study testing sessions, at 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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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
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose measurements in people with Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Hernandez, BS (562-787-0951, c1hernandez@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial fluid glucose readings (time frame: Hourly, up to 8 hours). 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 30 Jul 2020.