DiabetesPhase 1FASNCT01065948
A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
A Phase 1 study testing Subcutaneous glucose monitoring device in people with Diabetes, run by BioTex, Inc. at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Subcutaneous glucose monitoring device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.
Who cannot join
- Patients with fasting glucose concentration larger than 200 mg/dL will be excluded from the study.
- Children under the age of 18 will not be included because Texas state law would not allow such participants to give informed consent on their own.
- Patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (NSAIDs) and certain high-blood pressure medications will be excluded from the study.
- Pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. Presence of pacemaker or defibrillator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours
The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. The safety and comfort level of the device will also be studied.
Read the detailed description
The FAS glucose monitoring system is a minimally invasive glucose monitoring device which is not yet approved by the FDA. The FAS system will be used in this study to monitor glucose levels during a glucose tolerance test (GTT) performed in Dr.Orzeck practice. The FAS measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than 1 mm by inserting a small needle-like device. During the 4-hour GTT, the needle-like FAS is left in the skin tissue. The FAS performance has indicated in prior experiments that it is more stable than competitive commercial glucose-sensing devices. Due to its unique design, its glucose response is more accurate, and less affected by certain drugs (such as pain medicine).
- Conditions
- Diabetes
- Being tested
- Subcutaneous glucose monitoring device
- Keywords
- subcutaneous glucose monitoring, diabetes, fluorescence, affinity, biosensor, type I Diabetes, type II diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous glucose monitoring deviceDevice
Also called Fluorescence Affinity Sensor (FAS)
monitor interstitial glucose level every 5 min over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: Subcutaneous glucose monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method)
Measured: 3 months
monitor safety and performance of FAS response in two different body sites (abdomen, forearm)
Measured: 3 months
Secondary outcomes (2)
examine insertion site while the FAS is worn, and after seven days of FAS removal
Measured: 3 months
assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endocrinoloogy Associates Houston
- Responsible party
- Sponsor
- Investigators
- Ralph Dutt-Ballerstadt, Ph.D., Principal investigator, BioTex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065948
- Sponsor's protocol ID
- FAS-2009-05
- Acronym
- FAS
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2010
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours
- ClinicalTrials.gov ID
- NCT01065948
- Acronym / sponsor ID
- FAS / FAS-2009-05
- Conditions
- Diabetes
- Keywords
- subcutaneous glucose monitoring, diabetes, fluorescence, affinity, biosensor, type I Diabetes, type II diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BioTex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Endocrinoloogy Associates Houston
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Feb 2010 (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 goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. The safety and comfort level of the device will also be studied.
Detailed description
The FAS glucose monitoring system is a minimally invasive glucose monitoring device which is not yet approved by the FDA. The FAS system will be used in this study to monitor glucose levels during a glucose tolerance test (GTT) performed in Dr.Orzeck practice. The FAS measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than 1 mm by inserting a small needle-like device. During the 4-hour GTT, the needle-like FAS is left in the skin tissue. The FAS performance has indicated in prior experiments that it is more stable than competitive commercial glucose-sensing devices. Due to its unique design, its glucose response is more accurate, and less affected by certain drugs (such as pain medicine).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Subcutaneous glucose monitoring device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.
Key exclusion criteria (4 listed)
- Patients with fasting glucose concentration larger than 200 mg/dL will be excluded from the study.
- Children under the age of 18 will not be included because Texas state law would not allow such participants to give informed consent on their own.
- Patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (NSAIDs) and certain high-blood pressure medications will be excluded from the study.
- Pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. Presence of pacemaker or defibrillator.
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 |
|---|---|---|
| Subcutaneous glucose monitoring deviceAlso: Fluorescence Affinity Sensor (FAS)monitor interstitial glucose level every 5 min over 4 hours | Device | Patients |
Primary outcome
examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method)
Time frame: 3 months
monitor safety and performance of FAS response in two different body sites (abdomen, forearm)
Time frame: 3 months
2 secondary outcomes
examine insertion site while the FAS is worn, and after seven days of FAS removal
Time frame: 3 months
assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal
Time frame: 3 months
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 4 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Ralph Dutt-Ballerstadt, Ph.D. principal investigator
BioTex, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Subcutaneous glucose monitoring device in people with Diabetes, run by BioTex, Inc. 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 1 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: finished, as of the sponsor's last update on 4 Feb 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method) (time frame: 3 months). 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 4 Feb 2016.