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

NCT04776811 | Completed

• 1 other identifier: PDGS3
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean absolute relative difference (MARD)

  MARD of sensor versus YSI glucose

  5 minutes

Secondary Outcomes (7)

• Median absolute relative difference (MedARD)

  5 minutes

• Consensus Error grid analysis

  5 minutes

• Percent accuracy

  5 minutes

• Hypoglycemia detection rates

  15 minutes

• Hyperglycemia detection rates

  15 minutes

Interventions

Continuous glucose monitoring system DEVICE

Medtronic Guardian Connect with Guardian Sensor 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes patients on continuous ambulatory peritoneal dialysis

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
• \. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
• \. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period 16. Patients with history of pacemaker and prosthesis implantation.

Sponsors & Collaborators

• Elaine Chow: lead
• Medtronic Diabetes: collaborator

Study Sites (1)

Elaine Chow

Hong Kong, None Selected, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Disease; Kidney Failure, Chronic

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Elaine Chow, PhD, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)