Diabetes MellitusFIGS-2NCT02345967
Function of Implanted Glucose Sensor 2
A study testing Model 100 Sensor in people with Diabetes Mellitus, run by GlySens Incorporated at 2 sites in United States.
Trial summary
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Model 100 Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 30 May 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
- Diabetes diagnosis of type 1, or type 2 using insulin
- Under the routine care of a physician for diabetes treatment
- Able to understand and follow directions
- History of compliance with diabetes care regimen
- Able to comply with study requirements regarding planned clinical visits and exams
- In good physical condition without major medical concerns or blood chemistry abnormalities
Who cannot join
- Mental disorders that might affect compliance to protocols
- Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
- History of intolerance or sensitivity to any of the device materials
- History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
- History of recurrent skin infections
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Profil Institute for Clinical Research
Chula Vista, California, 91911
AMCR Institute
Escondido, California, 92025
About this study
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.
- Conditions
- Diabetes Mellitus
- Being tested
- Model 100 Sensor
- Keywords
- diabetes mellitus requiring insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 100 SensorDevice
One Model 100 Sensor to be implanted per subject.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Device: Model 100 Sensor Receives: Device: Model 100 Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Incidence of adverse events related to the Intervention
Measured: From enrollment to 2-weeks post-explant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion30 May 2018
- Study completion30 May 2018
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlySens Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institute for Clinical Research, Inc., AMCR Institute
- Responsible party
- Sponsor
- Investigators
- Linda Morrow, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345967
- Sponsor's protocol ID
- PR13-004
- Acronym
- FIGS-2
- Status last verified
- Jun 2018
- First submitted
- 20 Jan 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function of Implanted Glucose Sensor 2
- ClinicalTrials.gov ID
- NCT02345967
- Acronym / sponsor ID
- FIGS-2 / PR13-004
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus requiring insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlySens IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institute for Clinical Research, Inc., AMCR Institute
- Study start
- Jan 2015
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 26 Jan 2015 (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 purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Model 100 SensorDevice: Model 100 Sensor |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
- Diabetes diagnosis of type 1, or type 2 using insulin
- Under the routine care of a physician for diabetes treatment
- Able to understand and follow directions
- History of compliance with diabetes care regimen
Key exclusion criteria (5 listed)
- Mental disorders that might affect compliance to protocols
- Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
- History of intolerance or sensitivity to any of the device materials
- History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
- History of recurrent skin infections
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 |
|---|---|---|
| Model 100 SensorOne Model 100 Sensor to be implanted per subject. | Device | Study Group |
Primary outcome
Number of Adverse Events
Time frame: From enrollment to 2-weeks post-explant
Incidence of adverse events related to the Intervention
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 13 Jun 2018.
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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.
Linda Morrow, MD principal investigator
Profil Institute for Clinical Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model 100 Sensor in people with Diabetes Mellitus, run by GlySens Incorporated at 2 sites 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 7 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: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Number of Adverse Events (time frame: From enrollment to 2-weeks post-explant). 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 13 Jun 2018.