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Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System (BURST)
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).
Details
| Lead sponsor | Bigfoot Biomedical Inc. |
|---|---|
| Status | UNKNOWN |
| Enrolment | 500 |
| Start date | 2021-10-26 |
| Completion | 2025-02 |
Conditions
- Type 1 or Type 2 Diabetes
Interventions
- Bigfoot Unity Diabetes Management System
Primary outcomes
- Change from baseline in HbA1c — 3 months
Glycated hemoglobin - Change from baseline in HbA1c — 6 months
Glycated hemoglobin - Change from baseline in HbA1c — 9 months
Glycated hemoglobin - Change from baseline in HbA1c — 12 months
Glycated hemoglobin - 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
Countries
United States