Bigfoot Unity Real World Study

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System

Conditions
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Type 1 or Type 2 Diabetes

Intervention / Treatment
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* Device: Bigfoot Unity Diabetes Management System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or type 2 diabetes diagnosis HCP-prescribed, registered Bigfoot Unity users who have used the Bigfoot Unity System 2 weeks or less Age 12 years or older at time of electronic informed consent Using both long-acting and rapid-acting insulins that are compatible for use with the Bigfoot Unity System Using long-acting insulin no more than 1 time per day Must have baseline HbA1c collected within 90 days prior to starting the Bigfoot Unity System Able to read and understand English Participant or legally authorized representative for minors has the capacity to provide electronic informed consent Resident of the United States Persons who are using a phone that is compatible with Bigfoot Unity and not shared with a family member or a caregiver Exclusion Criteria: Females who are pregnant or intending to become pregnant during participation in the study Persons with implantable medical devices such as pacemakers Persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes Persons taking or expected to be taking >500mg Vitamin C supplements on routine basis Persons employed by the Sponsor or JCHR

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bigfoot Unity Diabetes Management System|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |