Diabetes MellitusNCT03417466
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
A study testing Enlite 1 connected to iPro2 recorder in people with Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 3 sites in China.
Trial summary
The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Enlite 1 connected to iPro2 recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesChina
- Study dates
- 28 Jun 2018to 20 Sep 2018
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 14 - 75 years of age at time of screening
- Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Subject has adequate venous access as assessed by investigator or appropriate staff
- Subject is willing to follow the study procedures and willing to come to study visits.
- Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days
Who cannot join
- Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
- Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
- Subject is female and plans to become pregnant during the course of the study
- Subject has a hematocrit (Hct) lower than the normal reference range
- Subject may not be on the research staff of those performing this study
Trial locations and contacts
3 sites in 1 country.
China3 sites
PLA Army General Hospital
Beijing, 100700
Sir Run Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou, 310016
Shanghai Sixth People's Hospital
Shanghai, 200233
About this study
The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
Read the detailed description
This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.
Each subject will wear the following devices:
- Two Enlite Sensors each connected to an iPro2 for approximately 6 days
Sensor Location:
- The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s.
During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).
During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.
- Conditions
- Diabetes Mellitus
- Being tested
- Enlite 1 connected to iPro2 recorder
- Keywords
- Diabetes Type I Type II
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlite 1 connected to iPro2 recorderDevice
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). Receives: Device: Enlite 1 connected to iPro2 recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days.
Measured: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Secondary outcomes (3)
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)
Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%).
Measured: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B represents sensor values that deviate YSI reference values by more than 20%, but "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.
Measured: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Consensus Error Grid (or Parkes error grid) compared the paired primary 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: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start28 Jun 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, MD, Principal investigator, Shanghai 6th People's HospitalXiaofeng Lv, MD, Principal investigator, PLA Army General HospitalHong Li, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417466
- Sponsor's protocol ID
- CIP313
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2018
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
- ClinicalTrials.gov ID
- NCT03417466
- Acronym / sponsor ID
- CIP313
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Type I Type II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 20 Aug 2019
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 demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
Detailed description
This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.
Each subject will wear the following devices:
- Two Enlite Sensors each connected to an iPro2 for approximately 6 days
Sensor Location:
- The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s.
During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).
During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Enlite 1 connected to iPro2 recorderUse Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 14 - 75 years of age at time of screening
- Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Subject has adequate venous access as assessed by investigator or appropriate staff
- Subject is willing to follow the study procedures and willing to come to study visits.
- Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days
Key exclusion criteria (8 listed)
- Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
- Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
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 |
|---|---|---|
| Enlite 1 connected to iPro2 recorderUse Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years. | Device | Study arm |
Primary outcome
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days.
3 secondary outcomes
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- 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.
Jian Zhou, MD principal investigator
Shanghai 6th People's Hospital
Xiaofeng Lv, MD principal investigator
PLA Army General Hospital
Hong Li, MD principal investigator
Sir Run Run Shaw Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enlite 1 connected to iPro2 recorder in people with Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 3 sites in China.
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 5 inclusion and 8 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). 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?
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) (time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)). 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 20 Aug 2019.