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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus (Diagnosis), End Stage Renal Disease, Dialysis

Intervention / Treatment
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* Device: Continuous glucose monitoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous glucose monitoring system|Medtronic Guardian Connect with Guardian Sensor 3|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute relative difference (MARD) | MARD of sensor versus YSI glucose | 5 minutes | 

Secondary Outcome Measures

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