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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months. Participants will be those with a prescription to use the Bigfoot Unity System. Medical practices prescribing Bigfoot Unity and Sponsor representatives will provide information about the study to current users and individuals considering initiation of the Bigfoot Unity System. During the course of the study, participants will be asked to use the Bigfoot Unity System in accordance with the prescription provided by their healthcare professional (HCP).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bigfoot Unity Diabetes Management System | Device | The Bigfoot Unity System is a wirelessly connected set of hardware and software that is intended for use by people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. Bigfoot Unity consists of the Abbott FreeStyle Libre 2 Sensor, two durable insulin pen caps (one each for specific rapid-acting and long-acting insulin pens) and an iOS-specific mobile App. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | Glycated hemoglobin | 3 months |
| Change from baseline in HbA1c | Glycated hemoglobin | 6 months |
| Change from baseline in HbA1c | Glycated hemoglobin | 9 months |
| Change from baseline in HbA1c | Glycated hemoglobin | 12 months |
| Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive | 3 months | |
| Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive | 6 months | |
| Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive | 9 months | |
| Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive | 12 months | |
| Glucose management indicator | 3 months | |
| Glucose management indicator | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of users 12 years or older who have type 1 or type 2 diabetes who are prescribed the Bigfoot Unity Diabetes Management System for managing their diabetes for multiple daily injections consistent with the labeling of the product.
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| Name | Affiliation | Role |
|---|---|---|
| Jim Malone, MD | Bigfoot Biomedical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bigfoot Biomedical Inc. | Milpitas | California | 95035 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Glucose management indicator |
| 9 months |
| Glucose management indicator | 12 months |
| Percent time Sensor in hypoglycemia | Will evaluate Sensor below 70 mg/dL and below 54 mg/dL | 3 months |
| Percent time Sensor in hypoglycemia | Will evaluate Sensor below 70 mg/dL and below 54 mg/dL | 6 months |
| Percent time Sensor in hypoglycemia | Will evaluate Sensor below 70 mg/dL and below 54 mg/dL | 9 months |
| Percent time Sensor in hypoglycemia | Will evaluate Sensor below 70 mg/dL and below 54 mg/dL | 12 months |
| Percent time Sensor in hyperglycemia | Will evaluate Sensor above 180 mg/dL and above 250 mg/dL | 3 months |
| Percent time Sensor in hyperglycemia | Will evaluate Sensor above 180 mg/dL and above 250 mg/dL | 6 months |
| Percent time Sensor in hyperglycemia | Will evaluate Sensor above 180 mg/dL and above 250 mg/dL | 9 months |
| Percent time Sensor in hyperglycemia | Will evaluate Sensor above 180 mg/dL and above 250 mg/dL | 12 months |
| Change from baseline in Diabetes Distress Scale | Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse. | 3 months |
| Change from baseline in Diabetes Distress Scale | Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse. | 6 months |
| Change from baseline in Diabetes Distress Scale | Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse. | 9 months |
| Change from baseline in Diabetes Distress Scale | Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse. | 12 months |
| Change from baseline in Hypoglycemia Confidence Scale | Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse. | 3 months |
| Change from baseline in Hypoglycemia Confidence Scale | Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse. | 6 months |
| Change from baseline in Hypoglycemia Confidence Scale | Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse. | 9 months |
| Change from baseline in Hypoglycemia Confidence Scale | Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse. | 12 months |
| Change from baseline in Insulin Delivery Satisfaction Survey | Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better. | 3 months |
| Change from baseline in Insulin Delivery Satisfaction Survey | Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better. | 6 months |
| Change from baseline in Insulin Delivery Satisfaction Survey | Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better. | 9 months |
| Change from baseline in Insulin Delivery Satisfaction Survey | Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better. | 12 months |
| System Usability Scale | Measures the usability of a system; scale is 0 to 100, higher scores are better. | 3 months |
| System Usability Scale | Measures the usability of a system; scale is 0 to 100, higher scores are better. | 6 months |
| System Usability Scale | Measures the usability of a system; scale is 0 to 100, higher scores are better. | 9 months |
| System Usability Scale | Measures the usability of a system; scale is 0 to 100, higher scores are better. | 12 months |
| D004700 | Endocrine System Diseases |