DiabetesNCT02423798
New Generation Enlite Accuracy Study
A study testing Glucose sensor (Enlite) in people with Diabetes, run by Medtronic MiniMed, Inc..
Trial summary
The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components. To evaluate the accuracy and performance of the new generation Enlite sensor. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Glucose sensor (Enlite)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed the informed consent form prior to screening
- Age 18-74 years (both inclusive)
- Subject has been diagnosed with T1DM
- Subject is current insulin pump user for at least 3 months
- HbA1c 9.5%
- With the exception of T1DM, the subject is considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and biochemical investigations as judged by the Investigator
Who cannot join
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence, vasectomized partner)
- Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
- Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
- Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
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- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 30 days
- Subject known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice).
- Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen according to locally used diagnostic testing
- Significant history of alcoholism or drug/chemical abuse as per investigator's judgment, current regular alcohol consumption of more than 1 unit per day for women and more than 2 units per day for men [1 unit of alcohol equals 1 beer (330 mL), 1 glass of wine (120 mL), or 1 glass of spirits (40 mL)], or a positive result in the urine drug/alcohol screen at the screening visit
About this study
Official title: Accuracy and Performance Evaluation of the Medtronic New Generation Enlite Glucose Sensor in Conjunction With the Medtronic 640G System Components - in Clinic and at Home
The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components.
To evaluate the accuracy and performance of the new generation Enlite sensor. This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial.
The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home.
Read the detailed description
The trial will investigate the accuracy and performance (i.e. the life-time) of a new sensor for CGM, the (new generation) Enlite glucose sensor, CE-marked in 2013, in conjunction with the new Medtronic 640G system components. Accuracy and life-time of the sensor are important parameters contributing to the safety of patients and patient acceptance of this still fairly new technology.
The current trial investigates the accuracy of the new sensor in conjunction with the new 640G system components both in the clinic and at home. This enables us to assess the sensor accuracy in a well-controlled environment using a highly accurate laboratory glucose analyzer as reference as well as sensor accuracy during real-life conditions using a blood glucose meter as reference analyzer.
The data gathered in this trial will help to understand the effect of technological advancements made and can guide future development of glucose sensor for continuous glucose monitoring.
- Conditions
- Diabetes
- Being tested
- Glucose sensor (Enlite)
- Keywords
- Diabetes, Glucose sensor, Sensor accuracy and performance, CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose sensor (Enlite)Device
This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial. The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and selfmonitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home. The trial will consist of 6 visits to the investigational site: a visit for informed consent procedures (Visit 0), a screening visit (Visit 1), 3 study visits (Visit 2-4) and a final examination (Visit 5).
| Study group | Role | What they receive |
|---|---|---|
| Open-label, single-sample design | Other | The trial has an open label design with a glucose sensor intervention. Only 1 sensor system is used in the trial (no comparator).
As all subjects will receive identical devices and undergo the same experimental procedures, no randomization will be performed. Furthermore, neither subjects nor clinical staff will be blinded to the sensor readings, as knowing the sensor glucose readings will not affect the accuracy endpoint. Receives: Device: Glucose sensor (Enlite) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor Accuracy
Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).
Measured: 4 months
Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values
All analysis performed using the Consensus Error Grid (or Parkes error grid) comparing the paired sensor and YSI reference glucose values.
Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action." Zone B as "altered clinical action with little or no effect on clinical outcome.". Ideal situation is 100% in Zone A + B.
Measured: 4 months
Sensor Survival
sensor survival in hours
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423798
- Sponsor's protocol ID
- CEP 296
- Status last verified
- Jan 2018
- First submitted
- 23 Mar 2015
- Last updated
- 17 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Performance Evaluation of the Medtronic New Generation Enlite Glucose Sensor in Conjunction With the Medtronic 640G System Components - in Clinic and at Home
- ClinicalTrials.gov ID
- NCT02423798
- Acronym / sponsor ID
- CEP 296
- Conditions
- Diabetes
- Keywords
- Diabetes, Glucose sensor, Sensor accuracy and performance, CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components.
To evaluate the accuracy and performance of the new generation Enlite sensor. This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial.
The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home.
Detailed description
The trial will investigate the accuracy and performance (i.e. the life-time) of a new sensor for CGM, the (new generation) Enlite glucose sensor, CE-marked in 2013, in conjunction with the new Medtronic 640G system components. Accuracy and life-time of the sensor are important parameters contributing to the safety of patients and patient acceptance of this still fairly new technology.
The current trial investigates the accuracy of the new sensor in conjunction with the new 640G system components both in the clinic and at home. This enables us to assess the sensor accuracy in a well-controlled environment using a highly accurate laboratory glucose analyzer as reference as well as sensor accuracy during real-life conditions using a blood glucose meter as reference analyzer.
The data gathered in this trial will help to understand the effect of technological advancements made and can guide future development of glucose sensor for continuous glucose monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label, single-sample design | Other | Device: Glucose sensor (Enlite)The trial has an open label design with a glucose sensor intervention. Only 1 sensor system is used in the trial (no comparator). As all subjects will receive identical devices and undergo the same experimental procedures, no randomization will be performed. Furthermore, neither subjects nor clinical staff will be blinded to the sensor readings, as knowing the sensor glucose readings will not affect the accuracy endpoint. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has signed the informed consent form prior to screening
- Age 18-74 years (both inclusive)
- Subject has been diagnosed with T1DM
- Subject is current insulin pump user for at least 3 months
- HbA1c 9.5%
Key exclusion criteria (10 listed)
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence, vasectomized partner)
- Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
- Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
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 |
|---|---|---|
| Glucose sensor (Enlite)This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial. The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and selfmonitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home. The trial will consist of 6 visits to the investigational site: a visit for informed consent procedures (Visit 0), a screening visit (Visit 1), 3 study visits (Visit 2-4) and a final examination (Visit 5). | Device | Open-label, single-sample design |
Primary outcome
Sensor Accuracy
Time frame: 4 months
Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).
Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values
Time frame: 4 months
All analysis performed using the Consensus Error Grid (or Parkes error grid) comparing the paired sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action." Zone B as "altered clinical action with little or no effect on clinical outcome.". Ideal situation is 100% in Zone A + B.
Sensor Survival
Time frame: 4 months
sensor survival in hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose sensor (Enlite) in people with Diabetes, run by Medtronic MiniMed, Inc..
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 6 inclusion and 10 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensor Accuracy (time frame: 4 months). The study lists 3 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 17 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.