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 |
|---|---|
| Institute for Diabetes-Technology GmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)
User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frazier 3 Verio | Device | In vitro diagnostic device (IVDD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument. | UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional) | Up to 1 hour |
| System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument. | Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only. | Up to 1 hour |
| System Use Evaluation questionnaire | Assessment of how the patient uses the BGMS. | Up to 15 minutes |
| Instructions for Use Evaluation questionnaire. | Questionnaires to assess the effectiveness of the instructions for use. | Up to 10 days. |
| Marketing Claims Evaluation questionnaire. | Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims. | Up to 10 days |
Not provided
Not provided
Summary of Inclusion Criteria
Summary of exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lorna Stewart | LifeScan Scotland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie | Ulm | D-89081 | Germany | |||
| Diabetes Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375031 | Derived | Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Frazier 3 UltraPlus |
| Device |
In vitro diagnostic device (IVDD) |
|
| Birmingham |
| B9 5SS |
| United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Centre for Health Science | Inverness | IV2 3JH | United Kingdom |