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
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.
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 →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.
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.
Exclusion Criteria:
13 Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
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.
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medtronic Guardian Connect with Guardian Sensor 3
Mean absolute relative difference (MARD)
MARD of sensor versus YSI glucose
Time frame: 5 minutes
Median absolute relative difference (MedARD)
MedARD of sensor versus YSI glucose
Time frame: 5 minutes
Consensus Error grid analysis
% sensor values in regions A and B
Time frame: 5 minutes
Percent accuracy
System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values
Time frame: 5 minutes
Hypoglycemia detection rates
True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate
Time frame: 15 minutes
Hyperglycemia detection rates
True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates
Time frame: 15 minutes
User satisfaction
Diabetes Satisfaction Treatment Questionnaire score
Time frame: 2 weeks
Correlation between CGM metrics, HbA1c and fructosamine
Correlation between CGM metrics, HbA1c and fructosamine
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
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.
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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Elaine Chow