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| Name | Class |
|---|---|
| Medtronic MiniMed, Inc. | INDUSTRY |
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Assessment of performance (precision and accuracy) of Guardian Sensorâ„¢ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring system | Device | Medtronic Guardian Connect with Guardian Sensor 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute relative difference (MARD) | MARD of sensor versus YSI glucose | 5 minutes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Diabetes patients on continuous ambulatory peritoneal dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow, PhD, MBChB | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elaine Chow | Hong Kong | None Selected | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004194 | Disease |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |