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CompletedNCT04776811Updated Nov 28, 2022

Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis

An observational study in Diabetes Mellitus (Diagnosis), End Stage Renal Disease and Dialysis, sponsored by Elaine Chow. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-28.

Sponsored by Elaine Chow · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus (Diagnosis)
  • End Stage Renal Disease
  • Dialysis
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 30 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Elaine Chow is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Diabetes patients on continuous ambulatory peritoneal dialysis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
  2. On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
  3. Male or female age ≥ 18 years old and ≤ 75 year old.
  4. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  5. 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.
  6. Willingness to abstain from swimming during their participation in the measurement phase.
  7. 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.
  8. Written to participate in the study provided by the patient.

Exclusion criteria

Exclusion Criteria:

  1. Poorly controlled diabetes mellitus with >11%
  2. Peritonitis within 1 month
  3. On icodextrin PD solutions
  4. Planned for switching to hemodialysis or living donor transplant in future 3 months
  5. Currently pregnant, as demonstrated by a positive pregnancy test at screening
  6. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  7. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  8. 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.
  9. 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).
  10. Have a known allergy to medical-grade adhesives, or known to any of the products used in the study.
  11. Blood donation of more than 500 ml within the last three months
  12. Currently participating in another 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.

  1. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
  1. Women of who are unwilling to adopt measures during the study period 16. Patients with history of pacemaker and prosthesis implantation.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DeviceContinuous glucose monitoring system

    Medtronic Guardian Connect with Guardian Sensor 3

06

What researchers measure

Primary outcomes

  1. Mean absolute relative difference (MARD)

    MARD of sensor versus YSI glucose

    Time frame: 5 minutes

Secondary outcomes

  1. Median absolute relative difference (MedARD)

    MedARD of sensor versus YSI glucose

    Time frame: 5 minutes

  2. Consensus Error grid analysis

    % sensor values in regions A and B

    Time frame: 5 minutes

  3. Percent accuracy

    System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values

    Time frame: 5 minutes

  4. Hypoglycemia detection rates

    True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate

    Time frame: 15 minutes

  5. Hyperglycemia detection rates

    True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates

    Time frame: 15 minutes

  6. User satisfaction

    Diabetes Satisfaction Treatment Questionnaire score

    Time frame: 2 weeks

  7. Correlation between CGM metrics, HbA1c and fructosamine

    Correlation between CGM metrics, HbA1c and fructosamine

    Time frame: 2 weeks

07

Study locations

1 site
  • Elaine Chow
    Hong Kong, None Selected, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Sep 2022, 18 months.

Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's 18 months is below that.

Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2021
First posted
Mar 2, 2021
StartActual
Mar 1, 2021
Primary completionActual
Sep 30, 2022
CompletionActual
Sep 30, 2022
Last update
Nov 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04776811
Lead sponsor
Elaine Chow
Collaborators
Medtronic Diabetes
Responsible party
Elaine Chow (Clinical Assistant Professor, Chinese University of Hong Kong) — Sponsor-investigator
First posted
Mar 2, 2021
Start date
Mar 1, 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Nov 28, 2022

Study contacts

Elaine Chow, PhD, MBChB
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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