Healthy SubjectsNCT03008044
Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense System)
A study testing FiberSense system in people with Healthy Subjects, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
Trial summary
This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- FiberSense system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2016to Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18 years old.
- Nondiabetic subjects with normal fasting plasma glucose and HbA1c (≤5.6%)
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- Willingness to abstain from bathing and swimming during their participation in the measurement phase.
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
- Written informed consent to participate in the study provided by the patient.
Who cannot join
- Currently pregnant, as demonstrated by a positive pregnancy test at screening and on day of first sensor insertion
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
- Impaired renal function measured as serum creatinine > 1.2 times above the upper limit of normal.
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
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- Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- Known current or recent alcohol or drug abuse
- Blood donation of more than 500 ml within the last three months
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- History of epilepsy
- History of cardiac arrhythmias
- Clinically significant abnormality on ECG at screening
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp
This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
Read the detailed description
The FiberSense system is intended to be used by diabetic patients in a home use setting as a CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose levels.The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
- Conditions
- Healthy Subjects
- Being tested
- FiberSense system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberSense systemDevice
A novel CGM system based on a FiberSense system placed through the dermis of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Device: FiberSense system | Experimental | 10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day. Receives: Device: FiberSense system |
| Extension Phase | Experimental | 2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study. Receives: Device: FiberSense system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall performance of the FiberSense device as compared with YSI
Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.
Measured: 1 day
Secondary outcomes (13)
Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Measured: 1 day
Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
Measured: 1 day
Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)
Measured: 1 day
Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions
Measured: 1 day
Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)
Measured: 1 day
Percentage of readings that are within 15% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Measured: 1 day
Percentage of readings that are within 20% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Measured: 1 day
Percentage of readings that are within 30% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Measured: 1 day
Percentage of readings that are within 40% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Measured: 1 day
Percentage of readings that are greater than 40% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Measured: 1 day
Adverse Event Reporting
Measured: 14 days
Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Measured: 1 day
Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
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 posted2 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- For the first 10 subjects, all sensors will be removed after the end of the clamp measurement day. The last 2 subjects will continue to wear the three sensors after the clamp study. The second clamp study will take place at Day 7±1. After the second clamp study, the commercial CGM sensor will be removed. The two FiberSense sensors will be worn for up to Day 14.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaine Chow, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008044
- Sponsor's protocol ID
- P-4.4-C-01
- Status last verified
- Aug 2017
- First submitted
- 16 Dec 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp
- ClinicalTrials.gov ID
- NCT03008044
- Acronym / sponsor ID
- P-4.4-C-01
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Jan 2017 (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.
This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
Detailed description
The FiberSense system is intended to be used by diabetic patients in a home use setting as a CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose levels.The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For the first 10 subjects, all sensors will be removed after the end of the clamp measurement day. The last 2 subjects will continue to wear the three sensors after the clamp study. The second clamp study will take place at Day 7±1. After the second clamp study, the commercial CGM sensor will be removed. The two FiberSense sensors will be worn for up to Day 14.
| Arm | Type | Receives |
|---|---|---|
| Device: FiberSense system | Experimental | Device: FiberSense system10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day. |
| Extension Phase | Experimental | Device: FiberSense system2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age ≥ 18 years old.
- Nondiabetic subjects with normal fasting plasma glucose and HbA1c (≤5.6%)
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- Willingness to abstain from bathing and swimming during their participation in the measurement phase.
Key exclusion criteria (15 listed)
- Currently pregnant, as demonstrated by a positive pregnancy test at screening and on day of first sensor insertion
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
- Impaired renal function measured as serum creatinine > 1.2 times above the upper limit of normal.
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
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 |
|---|---|---|
| FiberSense systemA novel CGM system based on a FiberSense system placed through the dermis of the patient. | Device | Device: FiberSense system, Extension Phase |
Primary outcome
Overall performance of the FiberSense device as compared with YSI
Time frame: 1 day
Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.
13 secondary outcomes
Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Time frame: 1 day
Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
Time frame: 1 day
Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)
Time frame: 1 day
Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions
Time frame: 1 day
Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)
Time frame: 1 day
Percentage of readings that are within 15% of the YSI values
Time frame: 1 day
Percentage of readings that are within 20% of the YSI values
Time frame: 1 day
Percentage of readings that are within 30% of the YSI values
Time frame: 1 day
Percentage of readings that are within 40% of the YSI values
Time frame: 1 day
Percentage of readings that are greater than 40% of the YSI values
Time frame: 1 day
Adverse Event Reporting
Time frame: 14 days
Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Time frame: 1 day
Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- 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.
Elaine Chow, Dr. principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberSense system in people with Healthy Subjects, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 2017. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall performance of the FiberSense device as compared with YSI (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 11 Aug 2017.