Diabetes MellitusPRECISENCT02154126
PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor
A study testing Continuous Glucose Monitoring Device (Senseonics) in people with Diabetes Mellitus, run by Senseonics, Inc. at 1 site in Netherlands.
Trial summary
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitoring Device (Senseonics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Nov 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following inclusion criteria will be included in this study:
- Males and females ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy)
- Subject has signed an informed consent document and is willing to comply with protocol requirements
Who cannot join
- Subjects meeting any of the following exclusion criteria will be excluded from this study:
- History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure
- Diabetic ketoacidosis in the past 6 months
- Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
- Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure
- Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy including active retinopathy
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- Hematocrit >50% or <30%
- Females lactating or pregnant or intending to become pregnant during the course of the investigation
- A condition requiring or likely to require magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). 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 Device (Senseonics)
- 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 Device (Senseonics)Device
| Study group | Role | What they receive |
|---|---|---|
| Accuracy assessment | Other | Not described Receives: Device: Continuous Glucose Monitoring Device (Senseonics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (mean absolute relative difference) compared to be reference device should be less than 20%
To determine accuracy of the Senseonics CGM System measurements over successive periods of 30 days of Sensor use through 180 days post-insertion.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J.Hans de Vries, MD, Principal investigator, Academic Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154126
- Sponsor's protocol ID
- CTP-0004
- Acronym
- PRECISE
- Status last verified
- May 2015
- First submitted
- 23 May 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JH. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care. 2017 Jan;40(1):63-68. doi: 10.2337/dc16-1525. Epub 2016 Nov 4.
PubMed 27815290
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor
- ClinicalTrials.gov ID
- NCT02154126
- Acronym / sponsor ID
- PRECISE / CTP-0004
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Jun 2014 (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 accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). 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 |
|---|---|---|
| Accuracy assessment | Other | Device: Continuous Glucose Monitoring Device (Senseonics) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy)
- Subject has signed an informed consent document and is willing to comply with protocol requirements
Key exclusion criteria (9 listed)
- Subjects meeting any of the following exclusion criteria will be excluded from this study:
- History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure
- Diabetic ketoacidosis in the past 6 months
- Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
- Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure
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 Device (Senseonics) | Device | Accuracy assessment |
Primary outcome
Accuracy (mean absolute relative difference) compared to be reference device should be less than 20%
Time frame: 90 days
To determine accuracy of the Senseonics CGM System measurements over successive periods of 30 days of Sensor use through 180 days post-insertion.
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 21 Jan 2016.
- Derived from this study: PubMed 27815290Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JH. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care. 2017 Jan;40(1):63-68. doi: 10.2337/dc16-1525. Epub 2016 Nov 4.
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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.
J.Hans de Vries, MD principal investigator
Academic Medical Centre
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 Device (Senseonics) in people with Diabetes Mellitus, run by Senseonics, Inc. at 1 site in Netherlands.
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 9 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 21 Jan 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 Netherlands. 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?
Accuracy (mean absolute relative difference) compared to be reference device should be less than 20% (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154126, which also lists 1 linked publication.
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 21 Jan 2016.