Bigfoot Unity Real World STudy (BURST)
Virtual, 6-month Study
Principal Investigator: Jim Malone, MD
Conducted by Jaeb Center for Health Research (JCHR)
Study Sponsor: Bigfoot Biomedical
Please contact your provider to find out if they are prescribing the Bigfoot Unity System.
Purpose of Study: The goal of this voluntary study is to collect real-world experiences and data from participants who are prescribed and using the Bigfoot Unity System. All information is collected electronically so the study does not require any office visits. Compensation is available for your time.
In addition to the regular use of the Bigfoot Unity System, participants will be asked to:
- Complete an initial electronic consent.
- Collect your blood samples by finger stick at home with provided A1C kits and answer additional questions electronically:
- At the beginning of the study
- After three months
- After six months
- Complete a safety survey every two weeks on your diabetes management and report if any serious events (such as hospitalization) have occurred.
Inclusion criteria: The study is accepting males and females ages 12 and older who:
- Have Type 1 or Type 2 diabetes.
- Have been prescribed Bigfoot Unity and not used the system for more than two weeks.
- Use insulin that is compatible with Bigfoot Unity.
- Use long-acting insulin no more than 1 time per day.
- Can read and understand the English language.
- Are able to understand the details of the consent form and provide your own consent (or consent for a minor if you are a LAR).
- Are a resident of the United States.
Participants may not:
- Be pregnant, or plan on becoming pregnant during the next 6 months.
- Have an implantable medical device, such as a pacemaker.
- Be on dialysis or have other serious medical conditions that would impact your ability to use the device or manage your diabetes.
- Be taking or expecting to take more than 500 mg of Vitamin C supplements on a routine basis in the next 6 months.
- Be employed by Bigfoot Biomedical or the Jaeb Center for Health Research.
If you decide to participate, you will be asked additional questions to confirm that you are eligible.
If you have any questions, contact the BURST Study team Monday through Friday 8 AM to 5 PM ET:
WEB-400079 Rev A