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

• ClinicalTrials.gov Identifier: NCT04776811
• Recruitment Status: Recruiting
• First Posted: March 2, 2021
• Last Update Posted: August 3, 2021
• Sponsor: Elaine Chow
• Collaborator: Medtronic Diabetes
• Information provided by (Responsible Party): Elaine Chow, Chinese University of Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment
Diabetes Mellitus (Diagnosis); End Stage Renal Disease; Dialysis	Device: Continuous glucose monitoring system

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Groups and Cohorts

Intervention Details:

• Device: Continuous glucose monitoring system
  Medtronic Guardian Connect with Guardian Sensor 3

Outcome Measures

Primary Outcome Measures :

1. Mean absolute relative difference (MARD) [ Time Frame: 5 minutes ]
   MARD of sensor versus YSI glucose

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Diabetes patients on continuous ambulatory peritoneal dialysis

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.

Contacts and Locations

Contacts

Contact: Elaine Chow, MBChB; +85235051549; e.chow@cuhk.edu.hk

Locations

China, None Selected

Elaine Chow; Recruiting

Hong Kong, None Selected, China

Contact: Elaine Chow e.chow@cuhk.edu.hk

Sub-Investigator: Jack Ng

Sponsors and Collaborators

Elaine Chow

Medtronic Diabetes

Investigators

• Principal Investigator: Elaine Chow, PhD, MBChB; Chinese University of Hong Kong

More Information

• Responsible Party: Elaine Chow, Clinical Assistant Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04776811
• Other Study ID Numbers: PDGS3
• First Posted: March 2, 2021
• Last Update Posted: August 3, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Failure, Chronic; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency