Diabetes MellitusNCT02933164
A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System in Canada
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Senseonics, Inc. at 1 site in Canada.
Trial summary
The purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Aug 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and Female Subjects meeting all of the following inclusion criteria will be included in this study:
- Subjects age ≥12 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
Who cannot join
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- History of hepatitis B, hepatitis C, or HIV
- Currently receiving (or likely to need during the study period):
Show all 14Show fewer
- immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis,endocarditis)
- A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
- Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- The presence of any other active implanted device (as defined further in protocol)
- The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDevice
Effectiveness and safety of a Continuous Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental | Evaluation of the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use. Receives: Device: Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM Relative Difference to Laboratory Reference reported as MARD
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017 (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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933164
- Sponsor's protocol ID
- CTP-0024
- Status last verified
- May 2017
- First submitted
- 12 Oct 2016
- Last updated
- 22 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System in Canada
- ClinicalTrials.gov ID
- NCT02933164
- Acronym / sponsor ID
- CTP-0024
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 14 Oct 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 purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Device: Continuous Glucose Monitoring SystemEvaluation of the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female Subjects meeting all of the following inclusion criteria will be included in this study:
- Subjects age ≥12 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
Key exclusion criteria (14 listed)
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- History of hepatitis B, hepatitis C, or HIV
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 |
|---|---|---|
| Continuous Glucose Monitoring SystemEffectiveness and safety of a Continuous Glucose Monitoring System | Device | Arms |
Primary outcome
CGM Relative Difference to Laboratory Reference reported as MARD
Time frame: 180 days
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Senseonics, Inc. at 1 site in Canada.
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 4 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 22 May 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 Canada. 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?
CGM Relative Difference to Laboratory Reference reported as MARD (time frame: 180 days). 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 22 May 2017.