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

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 Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Dialysis; Diabetes Mellitus (Diagnosis)
• Intervention / Treatment: Device: Continuous glucose monitoring system

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• China
  • None Selected
    • Hong Kong, None Selected, China
      • Elaine Chow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetes patients on continuous ambulatory peritoneal dialysis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute relative difference (MARD)	MARD of sensor versus YSI glucose	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median absolute relative difference (MedARD)	MedARD of sensor versus YSI glucose	5 minutes
Consensus Error grid analysis	% sensor values in regions A and B	5 minutes
Percent accuracy	System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values	5 minutes
Hypoglycemia detection rates	True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate	15 minutes
Hyperglycemia detection rates	True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates	15 minutes
User satisfaction	Diabetes Satisfaction Treatment Questionnaire score	2 weeks
Correlation between CGM metrics, HbA1c and fructosamine	Correlation between CGM metrics, HbA1c and fructosamine	2 weeks

Collaborators and Investigators

• Sponsor: Elaine Chow
• Collaborators: Medtronic Diabetes
• Investigators: Principal Investigator: Elaine Chow, PhD, MBChB, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Kidney Failure, Chronic
• Other Study ID Numbers: PDGS3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No