Diabetes MellitusSENSORNCT02800044
Studying the Effectiveness of Non-Invasive Glucose Sensors in Patients With Diabetes: The SENSOR Study
A study testing Wearing a non-invasive glucose sensor in people with Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
Trial summary
The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under… 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?
- Wearing a non-invasive glucose sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 27 Mar 2018
- 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
- Absence of cognitive impairment, as demonstrated by a Montreal Cognitive Assessment (MOCA) score greater than 26; those individuals with questionable cognitive ability will be screened with this instrument.
- Ability to provide informed consent for participation.
Who cannot join
- Individuals without diabetes
- Those who have a MOCA score of 26 or less
- Those who cannot speak or read English. The investigators 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 a cardiac, respiratory, or other condition that would preclude safely exercising at a moderate pace. Along with a medical history and physical examination by the PI, prospective participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to help determine those who may safely exercise for this study. One or more "yes" responses does not necessarily exclude an individual 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.
About this study
The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.
Read the detailed description
Self-monitoring of blood glucose (SMBG) can both facilitate and hinder adherence in patients with diabetes mellitus (DM). Readings provide real-time information on hypoglycemic and hyperglycemic excursions. These data are crucial to successfully managing this disease, as SMBG can help guide decisions on titrating medications, and can potentially encourage patient engagement. There are drawbacks. Piercing the skin to check glucose up to several times a day can be uncomfortable and obtrusive for a patient with DM. SMBG offers only a snapshot of the patient's glucose at the time of testing.
Continuous glucose monitoring (CGM) can reveal glucose trends. A subcutaneous sensor transmits interstitial glucose readings approximately every five minutes. Yet, sensor insertion requires a needle. Patients still must test SMBG about 4 times per day to calibrate the CGM sensor. This modality is less accurate with low or rapidly rising glucose. CGM is also not widely available, due to cost and insurance issues. A non-invasive glucose monitor, the GlucoWatch, was discontinued due to problems with accuracy and tolerability.
Compounding these challenges is the surging number of individuals with DM. Every 19 seconds, an American 20 years of age or older is diagnosed with DM. If current trends continue, 1 in 3 Americans could have DM by 2050.
There is thus an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Preliminary data from seven individuals without DM demonstrated correlation between glucose measurements from this sensor and a glucometer. Evaluating this sensor in patients with DM will be critical: while hour-to-hour blood glucose fluctuates approximately 50% throughout the day in those without DM, it may vary up to 10-fold in patients with DM. This study would be the first to examine this sensor in individuals with DM. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure glucose in patients with DM.
- Conditions
- Diabetes Mellitus
- Being tested
- Wearing a non-invasive glucose sensor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing a non-invasive glucose sensorDevice
Glucose readings will be obtained from both a glucometer (fingerstick readings) and from the non-invasive glucose sensor at the following four timepoints: fasting, 1.5 to 2 hours after consuming a meal, and before and after 15-30 minutes of moderate exercise on a stationary bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Wearing glucose sensor | Experimental | The study team will measure glucose readings from the non-invasive sensor and from a glucometer at the following time points: fasting, 1.5 to 2 hours after a meal, and before and after 15-30 minutes of pedaling on a stationary bicycle at 80% maximum heart rate.. Receives: Device: Wearing a non-invasive glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
how the non-invasive glucose sensor measurements correlate with glucometer readings
Measured: 1 year
Secondary outcomes (1)
acceptability
how acceptable patients find this sensor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start14 Mar 2017
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Why it stopped: Results were not accurate; despite multiple efforts to troubleshoot.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 6 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, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800044
- Sponsor's protocol ID
- UCSDSOM
- Acronym
- SENSOR
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bandodkar AJ, Jia W, Yardimci C, Wang X, Ramirez J, Wang J. Tattoo-based noninvasive glucose monitoring: a proof-of-concept study. Anal Chem. 2015 Jan 6;87(1):394-8. doi: 10.1021/ac504300n. Epub 2014 Dec 12.
PubMed 25496376
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
- Studying the Effectiveness of Non-Invasive Glucose Sensors in Patients With Diabetes: The SENSOR Study
- ClinicalTrials.gov ID
- NCT02800044
- Acronym / sponsor ID
- SENSOR / UCSDSOM
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results were not accurate; despite multiple efforts to troubleshoot.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.
Detailed description
Self-monitoring of blood glucose (SMBG) can both facilitate and hinder adherence in patients with diabetes mellitus (DM). Readings provide real-time information on hypoglycemic and hyperglycemic excursions. These data are crucial to successfully managing this disease, as SMBG can help guide decisions on titrating medications, and can potentially encourage patient engagement. There are drawbacks. Piercing the skin to check glucose up to several times a day can be uncomfortable and obtrusive for a patient with DM. SMBG offers only a snapshot of the patient's glucose at the time of testing.
Continuous glucose monitoring (CGM) can reveal glucose trends. A subcutaneous sensor transmits interstitial glucose readings approximately every five minutes. Yet, sensor insertion requires a needle. Patients still must test SMBG about 4 times per day to calibrate the CGM sensor. This modality is less accurate with low or rapidly rising glucose. CGM is also not widely available, due to cost and insurance issues. A non-invasive glucose monitor, the GlucoWatch, was discontinued due to problems with accuracy and tolerability.
Compounding these challenges is the surging number of individuals with DM. Every 19 seconds, an American 20 years of age or older is diagnosed with DM. If current trends continue, 1 in 3 Americans could have DM by 2050.
There is thus an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Preliminary data from seven individuals without DM demonstrated correlation between glucose measurements from this sensor and a glucometer. Evaluating this sensor in patients with DM will be critical: while hour-to-hour blood glucose fluctuates approximately 50% throughout the day in those without DM, it may vary up to 10-fold in patients with DM. This study would be the first to examine this sensor in individuals with DM. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure glucose in patients with DM.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearing glucose sensor | Experimental | Device: Wearing a non-invasive glucose sensorThe study team will measure glucose readings from the non-invasive sensor and from a glucometer at the following time points: fasting, 1.5 to 2 hours after a meal, and before and after 15-30 minutes of pedaling on a stationary bicycle at 80% maximum heart rate.. |
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
- Absence of cognitive impairment, as demonstrated by a Montreal Cognitive Assessment (MOCA) score greater than 26; those individuals with questionable cognitive ability will be screened with this instrument.
- Ability to provide informed consent for participation.
Key exclusion criteria (5 listed)
- Individuals without diabetes
- Those who have a MOCA score of 26 or less
- Those who cannot speak or read English. The investigators 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 a cardiac, respiratory, or other condition that would preclude safely exercising at a moderate pace. Along with a medical history and physical examination by the PI, prospective participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to help determine those who may safely exercise for this study. One or more "yes" responses does not necessarily exclude an individual 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 |
|---|---|---|
| Wearing a non-invasive glucose sensorGlucose readings will be obtained from both a glucometer (fingerstick readings) and from the non-invasive glucose sensor at the following four timepoints: fasting, 1.5 to 2 hours after consuming a meal, and before and after 15-30 minutes of moderate exercise on a stationary bicycle. | Device | Wearing glucose sensor |
Primary outcome
accuracy
Time frame: 1 year
how the non-invasive glucose sensor measurements correlate with glucometer readings
1 secondary outcome
acceptability
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Results were not accurate; despite multiple efforts to troubleshoot.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 25496376Bandodkar AJ, Jia W, Yardimci C, Wang X, Ramirez J, Wang J. Tattoo-based noninvasive glucose monitoring: a proof-of-concept study. Anal Chem. 2015 Jan 6;87(1):394-8. doi: 10.1021/ac504300n. Epub 2014 Dec 12.
- 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 Wearing a non-invasive glucose sensor 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 3 inclusion and 5 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: stopped early, 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?
The study was stopped early (reason given: Results were not accurate; despite multiple efforts to troubleshoot.). Results are not available in the source record.
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800044, which also lists 1 linked publication.
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.