Clinical trial NCT04776811: Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
Official title: Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus (Diagnosis)
End Stage Renal Disease
Dialysis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Medtronic Diabetes
First posted: 2021-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes patients on continuous ambulatory peritoneal dialysis

Brief 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.


Eligibility criteria: 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 informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Poorly controlled diabetes mellitus with HbA1c\>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 hypersensitivity 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 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.

Primary outcomes:
measure: Mean absolute relative difference (MARD)
timeFrame: 5 minutes
Secondary outcomes:
measure: Median absolute relative difference (MedARD)
timeFrame: 5 minutes
measure: Consensus Error grid analysis
timeFrame: 5 minutes
measure: Percent accuracy
timeFrame: 5 minutes
measure: Hypoglycemia detection rates
timeFrame: 15 minutes
measure: Hyperglycemia detection rates
timeFrame: 15 minutes
measure: User satisfaction
timeFrame: 2 weeks
measure: Correlation between CGM metrics, HbA1c and fructosamine
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Elaine Chow
state: None Selected
Study officials:
affiliation: Chinese University of Hong Kong
name: Elaine Chow, PhD, MBChB
role: PRINCIPAL_INVESTIGATOR
References: