Bigfoot Unity Real World Study (BURST)

Bigfoot Biomedical

Status: Invitation-only

Conditions: Type 1 or Type 2 Diabetes

Treatments: Device: Bigfoot Unity Diabetes Management System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05088265

21BF01

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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