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To evaluate the feasibility of the DexBasal Study System
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexbasal | Other | Subjects initiating basal insulin therapy or on basal insulin therapy maintenance and benefit from transitioning to a study-specific type of basal insulin within 72 hours of Phase 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basal insulin | Drug | daily basal insulin dose |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of participant safety while using the DexBasal Study System | Subject safety measured by the number of Severe Adverse Events (SAEs) | Day 10 up to 8 weeks |
| Measurement of system recommended dose | System functionality measured by the generation of a recommended dose. | Day 10 up to 8 weeks |
| Frequency of Physician approval of Dexbasal Study system's daily dose recommendation | System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2. | Day 10 up to 8 weeks |
| Subject reported insulin dose | System functionality measured by the subject-reported basal insulin dose injections. | Day 10 up to 8 weeks |
| Evaluation of the CGM Metrics based on average glucose | -Measure of Average glucose (mg/dL) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics using coefficient variation (CV) | - Measure of CV (%) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics for time in range (TIR) | - Measure of TIR (70-180 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gain understanding and perspective from study subjects with questionnaires | - Diabetes Treatment and Satisfaction Questionnaire change measures | End of study, on average Day 96 |
| Gain understanding and perspective from study subjects through status questionnaire |
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Inclusion Criteria: Patients with a diagnosis of Type 2 diabetes (T2D) mellitus
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Family Care (SDFC) | San Diego | California | 92111 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| Dexcom Continuous Glucose Monitoring (CGM) | Device | Dexcom Continuous Glucose Monitoring (CGM) Sensor |
|
| Evaluation of the CGM Metrics of time spent very low | - Measure of Time spent very low (<54 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics of time spent low | - Measure of Time spent low (54-69 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics of time spent below 70 mg/dL | - Measure of Time spent low (<70 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics of time spent high | - Measure of Time spent high (>180 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Evaluation of the CGM Metrics of time spent very high | - Measure of Time spent very high (>250 mg/dL) (%) | Baseline through end of study, an average of 96 days |
| Measure of glycemic control | Fasting Glucose | Baseline through end of study, an average of 96 days |
- Diabetes Treatment and Satisfaction Questionnaire status measures |
| Baseline |
| Gain understanding and perspective from study subjects through Relationship Scale | - Patient-Doctor Depth of Relationship Scale minimum score is zero, maximum score is 32. Higher score means a better outcome. | Baseline through end of study, an average of 96 days |
| Gain understanding and perspective from study subjects through Satisfaction Survey | - Glucose Monitoring Satisfaction Survey | Baseline through end of study, an average of 96 days |
| Gain understanding and perspective from study subjects thru study specific items | - Study-specific items | Baseline through end of study, an average of 96 days |