Diabetes Mellitus (Diagnosis)NCT04776811
Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
An observational study of Diabetes Mellitus (Diagnosis) and End Stage Renal Disease, run by Elaine Chow at 1 site in China.
Trial summary
Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus (Diagnosis), End Stage Renal Disease, Dialysis
- What is being tested?
- Continuous glucose monitoring system
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Sep 2022
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetes patients on continuous ambulatory peritoneal dialysis
Who may be able to join
- Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
- On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
- Male or female age ≥ 18 years old and ≤ 75 year old.
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- Willingness to abstain from swimming during their participation in the measurement phase.
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
- Written informed consent to participate in the study provided by the patient.
Who cannot join
- Poorly controlled diabetes mellitus with HbA1c>11%
- Peritonitis within 1 month
- On icodextrin PD solutions
- Planned for switching to hemodialysis or living donor transplant in future 3 months
- Currently pregnant, as demonstrated by a positive pregnancy test at screening
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
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- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- Blood donation of more than 500 ml within the last three months
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- 13 Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
- 14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
- 15. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period 16. Patients with history of pacemaker and prosthesis implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.
- Being tested
- Continuous glucose monitoring system
- Medical subject headings
- Diabetes Mellitus, Disease, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring systemDevice
Medtronic Guardian Connect with Guardian Sensor 3
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute relative difference (MARD)
MARD of sensor versus YSI glucose
Measured: 5 minutes
Secondary outcomes (7)
Median absolute relative difference (MedARD)
MedARD of sensor versus YSI glucose
Measured: 5 minutes
Consensus Error grid analysis
% sensor values in regions A and B
Measured: 5 minutes
Percent accuracy
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values
Measured: 5 minutes
Hypoglycemia detection rates
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
Measured: 15 minutes
Hyperglycemia detection rates
True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates
Measured: 15 minutes
User satisfaction
Diabetes Satisfaction Treatment Questionnaire score
Measured: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
Correlation between CGM metrics, HbA1c and fructosamine
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (Diagnosis)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine Chow
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Responsible party
- Sponsor-investigator, Elaine Chow, Chinese University of Hong Kong
- Investigators
- Elaine Chow, PhD, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776811
- Sponsor's protocol ID
- PDGS3
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT04776811
- Acronym / sponsor ID
- PDGS3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elaine ChowUniversity, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- 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.
Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes patients on continuous ambulatory peritoneal dialysis
Key inclusion criteria (8 listed)
- Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
- On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
- Male or female age ≥ 18 years old and ≤ 75 year old.
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
Key exclusion criteria (15 listed)
- Poorly controlled diabetes mellitus with HbA1c>11%
- Peritonitis within 1 month
- On icodextrin PD solutions
- Planned for switching to hemodialysis or living donor transplant in future 3 months
- Currently pregnant, as demonstrated by a positive pregnancy test at screening
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 systemMedtronic Guardian Connect with Guardian Sensor 3 | Device | – |
Primary outcome
Mean absolute relative difference (MARD)
Time frame: 5 minutes
MARD of sensor versus YSI glucose
7 secondary outcomes
Median absolute relative difference (MedARD)
Time frame: 5 minutes
Consensus Error grid analysis
Time frame: 5 minutes
Percent accuracy
Time frame: 5 minutes
Hypoglycemia detection rates
Time frame: 15 minutes
Hyperglycemia detection rates
Time frame: 15 minutes
User satisfaction
Time frame: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
Time frame: 2 weeks
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 28 Nov 2022.
- 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.
Elaine Chow, PhD, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus (Diagnosis) and End Stage Renal Disease, run by Elaine Chow at 1 site 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 8 inclusion and 15 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 28 Nov 2022. 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 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?
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?
Mean absolute relative difference (MARD) (time frame: 5 minutes). 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 28 Nov 2022.