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

Completed

• Conditions: Diabetes Mellitus (Diagnosis); End Stage Renal Disease; Dialysis

• Registration Number: NCT04776811
• Lead Sponsor: Elaine Chow

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-27
• Study First Submitted QC: 2021-02-27
• Study Start: 2021-03-01
• Study First Posted: 2021-03-02
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean absolute relative difference (MARD)	5 minutes	MARD of sensor versus YSI glucose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Elaine Chow; 🇨🇳 Hong Kong, None Selected, China