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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776811
• Other study ID #: PDGS3
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus (Diagnosis)
• Dialysis
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Elaine Chow	Hong Kong	None Selected

Sponsors (2)

Lead Sponsor	Collaborator
Elaine Chow	Medtronic Diabetes

Country where clinical trial is conducted

China, 

Outcome

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