Status:
COMPLETED
Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis
Lead Sponsor:
Elaine Chow
Collaborating Sponsors:
Medtronic Diabetes
Conditions:
Diabetes Mellitus (Diagnosis)
End Stage Renal Disease
Eligibility:
All Genders
18-75 years
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.
Eligibility Criteria
Inclusion
- Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
- On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
- Male or female age ≥ 18 years old and ≤ 75 year old.
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- 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.
- Willingness to abstain from swimming during their participation in the measurement phase.
- 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.
- Written informed consent to participate in the study provided by the patient.
Exclusion
- Poorly controlled diabetes mellitus with HbA1c\>11%
- Peritonitis within 1 month
- On icodextrin PD solutions
- Planned for switching to hemodialysis or living donor transplant in future 3 months
- Currently pregnant, as demonstrated by a positive pregnancy test at screening
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- 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.
- 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).
- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- Blood donation of more than 500 ml within the last three months
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04776811
Start Date
March 1 2021
End Date
September 30 2022
Last Update
November 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Elaine Chow
Hong Kong, None Selected, China