Bigfoot Unity Real World Study

Status unconfirmed

Conditions studied: Type 1 or Type 2 Diabetes

In brief

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).

Key facts

Study ID

NCT05088265

Run by

Bigfoot Biomedical Inc.

People needed

500

Starts

2021-10-26

Expected to finish

2025-02-01

Last updated by the study team

2023-02-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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