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

NCT ID: NCT04776811

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-09-30

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.

Conditions

Diabetes Mellitus (Diagnosis); End Stage Renal Disease; Dialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Continuous glucose monitoring system

Medtronic Guardian Connect with Guardian Sensor 3

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: collaborator

Elaine Chow

OTHER

Sponsor Role: lead

Responsible Party

Elaine Chow

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elaine Chow, PhD, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Elaine Chow

Hong Kong, None Selected, China

Countries

China

Other Identifiers

PDGS3

Identifier Type: -

Identifier Source: org_study_id