Bigfoot Unity Real World Study (BURST)

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 1 or Type 2 Diabetes
• Intervention / Treatment: Device: Bigfoot Unity Diabetes Management System

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Milpitas, California, United States, 95035
      • Bigfoot Biomedical Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Type 1 or type 2 diabetes diagnosis
2. HCP-prescribed, registered Bigfoot Unity users who have used the Bigfoot Unity System 2 weeks or less
3. Age 12 years or older at time of electronic informed consent
4. Using both long-acting and rapid-acting insulins that are compatible for use with the Bigfoot Unity System
5. Using long-acting insulin no more than 1 time per day
6. Must have baseline HbA1c collected within 90 days prior to starting the Bigfoot Unity System
7. Able to read and understand English
8. Participant or legally authorized representative for minors has the capacity to provide electronic informed consent
9. Resident of the United States
10. Persons who are using a phone that is compatible with Bigfoot Unity and not shared with a family member or a caregiver

Exclusion Criteria:

1. Females who are pregnant or intending to become pregnant during participation in the study
2. Persons with implantable medical devices such as pacemakers
3. Persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes
4. Persons taking or expected to be taking >500mg Vitamin C supplements on routine basis
5. Persons employed by the Sponsor or JCHR

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HbA1c	Glycated hemoglobin	6 months
Change from baseline in HbA1c	Glycated hemoglobin	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.	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.	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.	3 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.	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.	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.	9 months
System Usability Scale	Measures the usability of a system; scale is 0 to 100, higher scores are better.	12 months

Collaborators and Investigators

• Sponsor: Bigfoot Biomedical Inc.
• Collaborators: Jaeb Center for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21BF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No