Diabetes MellitusNCT03008239
Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense)
A study testing FiberSense sensor and Dexcom Sensor in people with Diabetes Mellitus, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
Trial summary
This study evaluates the performance and safety of the fluorescence based fibre optic glucose sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who require continuous ambulatory peritoneal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FiberSense sensor and Dexcom Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Nov 2017to Oct 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I or II diabetes mellitus requiring insulin in the management of glucose control for at least one year prior to enrollment or diabetes on continuous ambulatory peritoneal dialysis or prediabetic individuals with impaired fasting glucose or impaired glucose tolerance by OGTT
- Male or female age ≥ 18 years old and ≤ 70 year old.
- 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 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
- Poorly controlled diabetes mellitus with HbA1C >11%.
- Currently pregnant, as demonstrated by a positive pregnancy test at screening and on Day00 .
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
- 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.
- Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
- Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals
This study evaluates the performance and safety of the fluorescence based fibre optic glucose sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subjects.
Read the detailed description
The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management. The System is intended for use by patients at home and in health care facilities.
The FiberSense system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.
- Conditions
- Diabetes Mellitus
- Being tested
- FiberSense sensor, Dexcom 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.
FiberSense sensorDevice
The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management.
Dexcom SensorDevice
Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.
| Study group | Role | What they receive |
|---|---|---|
| FiberSense sensor | Experimental | Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks.
In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subject. Receives: Device: FiberSense sensor; Device: Dexcom Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
The primary endpoint is the proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl, and the proportion of FiberSense readings within ≤15 mg/dl of the YSI reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.
Measured: 28 days
Adverse Events reporting
Measured: 35 days
Secondary outcomes (14)
Mean Relatives Differences from YSI
Measured: 28 days
Median Relatives Differences from YSI
Measured: 28 days
Mean Absolute Relative Differences from YSI
Measured: 28 days
Median Absolute Relative Differences from YSI
Measured: 28 days
Hypoglycemia detection rates
Measured: 28 days
Hyperglycemia detection rates
Measured: 28 days
Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI
Measured: 28 days
Lag time between FiberSense readings and YSI results during induced glucose excursions
Measured: 28 days
Agreement and accuracy relative to SMBG readings (same model to be used by all subjects)
Measured: 28 days
Calibration stability
Measured: 28 days
Sensor stability
Measured: 28 days
Sensor life
Measured: 28 days
User satisfaction questionnaire score
Measured: 28 days
Blood maltose concentrations
Measured in CAPD subjects during the V1 in-clinic session
Measured: 28 days
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 start14 Nov 2017
- Primary completion10 Jul 2019
- Study completionOct 2019 (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.
- 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
- 26 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
- NCT03008239
- Sponsor's protocol ID
- P-4.5-C-01
- Status last verified
- Sep 2019
- First submitted
- 16 Dec 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals
- ClinicalTrials.gov ID
- NCT03008239
- Acronym / sponsor ID
- P-4.5-C-01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- Oct 2019 (estimated)
- 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 study evaluates the performance and safety of the fluorescence based fibre optic glucose sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subjects.
Detailed description
The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management. The System is intended for use by patients at home and in health care facilities.
The FiberSense system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FiberSense sensor | Experimental | Device: FiberSense sensor, Device: Dexcom SensorType 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subject. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type I or II diabetes mellitus requiring insulin in the management of glucose control for at least one year prior to enrollment or diabetes on continuous ambulatory peritoneal dialysis or prediabetic individuals with impaired fasting glucose or impaired glucose tolerance by OGTT
- Male or female age ≥ 18 years old and ≤ 70 year old.
- 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 swimming during their participation in the measurement phase.
Key exclusion criteria (14 listed)
- Poorly controlled diabetes mellitus with HbA1C >11%.
- Currently pregnant, as demonstrated by a positive pregnancy test at screening and on Day00 .
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
- 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 sensorThe FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management. | Device | FiberSense sensor |
| Dexcom SensorDexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend. | Device | FiberSense sensor |
Primary outcome
Blood glucose
Time frame: 28 days
The primary endpoint is the proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl, and the proportion of FiberSense readings within ≤15 mg/dl of the YSI reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.
Adverse Events reporting
Time frame: 35 days
14 secondary outcomes
Mean Relatives Differences from YSI
Time frame: 28 days
Median Relatives Differences from YSI
Time frame: 28 days
Mean Absolute Relative Differences from YSI
Time frame: 28 days
Median Absolute Relative Differences from YSI
Time frame: 28 days
Hypoglycemia detection rates
Time frame: 28 days
Hyperglycemia detection rates
Time frame: 28 days
Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI
Time frame: 28 days
Lag time between FiberSense readings and YSI results during induced glucose excursions
Time frame: 28 days
Agreement and accuracy relative to SMBG readings (same model to be used by all subjects)
Time frame: 28 days
Calibration stability
Time frame: 28 days
Sensor stability
Time frame: 28 days
Sensor life
Time frame: 28 days
User satisfaction questionnaire score
Time frame: 28 days
Blood maltose concentrations
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- 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 sensor and Dexcom Sensor in people with Diabetes Mellitus, 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 14 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 24 Sep 2019. 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?
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?
Blood glucose (time frame: 28 days). The study lists 2 primary outcomes in all. 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 24 Sep 2019.