Diabetes MellitusNCT03710083
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
A study testing Guardian™ Sensor (3) 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 Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System. 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?
- Guardian™ Sensor (3)
- 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 Feb 2019to 25 Jul 2019
- 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
Who cannot join
- Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) 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
The Seventh Medical Center of PLA General Hospital
Beijing, 100700
Sir Run Run Shaw Hospital
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 Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
Read the detailed description
This study is a multi-center, prospective single-arm 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.
During the study, each subject will be randomly assigned to one day of the Yellow Springs Instrument (YSI™*) frequent sample testing (FST) (Day 1, 3-5, or 7).Subjects will wear two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days (one which will be paired to the Guardian Connect app and the other will function as a glucose recorder.).
The Guardian Sensor (3)s will be worn in the abdomen area and self-inserted by the subject on same side or opposite sides.
On the evening prior to FST, subjects will be asked to fast for approximately 12 hours and adjust their insulin and medications according to routine care (for example as they would do for fasting lipid panel). Subjects may fast for shorter period of time based on investigator discretion.
The subject should be in fasting status upon arrival hospital to start FST process. The feeding protocol may be modified based on investigator discretion. The duration of FST will be approximately 7 hours.
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 CONTOUR™* study meter) for the management of their diabetes. The CONTOUR™* study meter may be used for treatment decisions and calibration of Guardian™ Sensor (3).
- Conditions
- Diabetes Mellitus
- Being tested
- Guardian™ Sensor (3)
- 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.
Guardian™ Sensor (3)Device
Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Receives: Device: Guardian™ Sensor (3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI
Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days.
Measured: 168 Hours
Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B
A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. 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: 168 Hours
Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B
A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.
Measured: 168 Hours
Mean Absolute Relative Difference (MARD)
Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple FST days were pooled together for reporting purpose.
Measured: 168 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start28 Feb 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
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, Seventh Medical Center of PLA Army General HospitalHong Li, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710083
- Sponsor's protocol ID
- CIP320
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2018
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
- ClinicalTrials.gov ID
- NCT03710083
- Acronym / sponsor ID
- CIP320
- 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 Feb 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 21 Aug 2020
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 Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
Detailed description
This study is a multi-center, prospective single-arm 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.
During the study, each subject will be randomly assigned to one day of the Yellow Springs Instrument (YSI™*) frequent sample testing (FST) (Day 1, 3-5, or 7).Subjects will wear two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days (one which will be paired to the Guardian Connect app and the other will function as a glucose recorder.).
The Guardian Sensor (3)s will be worn in the abdomen area and self-inserted by the subject on same side or opposite sides.
On the evening prior to FST, subjects will be asked to fast for approximately 12 hours and adjust their insulin and medications according to routine care (for example as they would do for fasting lipid panel). Subjects may fast for shorter period of time based on investigator discretion.
The subject should be in fasting status upon arrival hospital to start FST process. The feeding protocol may be modified based on investigator discretion. The duration of FST will be approximately 7 hours.
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 CONTOUR™* study meter) for the management of their diabetes. The CONTOUR™* study meter may be used for treatment decisions and calibration of Guardian™ Sensor (3).
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: Guardian™ Sensor (3)Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 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
Key exclusion criteria (8 listed)
- Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) 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 |
|---|---|---|
| Guardian™ Sensor (3)Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days. | Device | Study arm |
Primary outcome
Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI
Time frame: 168 Hours
Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days.
Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B
Time frame: 168 Hours
A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. 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.
Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B
Time frame: 168 Hours
A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.
Mean Absolute Relative Difference (MARD)
Time frame: 168 Hours
Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple FST days were pooled together for reporting purpose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Seventh Medical Center of 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 Guardian™ Sensor (3) 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 4 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 9 Sep 2020. 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 21 Aug 2020). 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?
Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI (time frame: 168 Hours). The study lists 4 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 9 Sep 2020.