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Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.
During ASCEND, patients will complete a single visit clinical study divided into two distinct parts. Part 1 involves each subject completing a number of simple quantitative exercises to gauge their level of comprehension of diabetes related information. Subjects will then continue during the same visit to complete part 2 which involves gathering qualitative feedback from each subject on the new Blood glucose monitoring system.
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| Measure | Description | Time Frame |
|---|---|---|
| Scaled preference questionnaires on new blood glucose monitoring digital tool. | Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects. | Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. | 1 hour |
| Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 150 male or female subjects with Type 1 or Type 2 Diabetes Mellitus.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Grady | LifeScan Scotland Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Birmingham | United Kingdom | ||||
| Royal Infirmary of Edinburgh |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. |
| 1 hour |
| Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c. | Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. | 1 hour |
| Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy. | Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. | 1 hour |
| Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects | Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive. | 1 hour |
| Edinburgh |
| United Kingdom |
| Highland Clinical Research Facility | Inverness | United Kingdom |