Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic MiniMed, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Assessment of performance (precision and accuracy) of Simpleraâ„¢ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring system | Device | Medtronic Simpleraâ„¢ |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Diabetes patients on continuous ambulatory peritoneal dialysis on icodextrin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elaine Chow Clinical Associate Professor, MBChB | Contact | +85235051549 | e.chow@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow Clinical Associate Professor, PhD, MBChB | Department of Medicine and Therapeutics, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine and Therapeutics, The Chinese University of Hong Kong | Hong Kong | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 minutes |
| Percent accuracy | System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI value | 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 Time Frame: 2 weeks and | 2 weeks |
| Correlation between CGM metrics, HbA1c and fructosamine | Correlation between CGM metrics, HbA1c and fructosamine | 2 weeks |
| Correlation between CGM metrics and SMBG | Correlation between CGM metrics and SMBG | 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 |