Clinical trial NCT05088265: Bigfoot Unity Real World Study
Official title: Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 or Type 2 Diabetes
Lead sponsor: Bigfoot Biomedical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2021-10-21
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: 3 months
measure: Change from baseline in HbA1c
timeFrame: 6 months
measure: Change from baseline in HbA1c
timeFrame: 9 months
measure: Change from baseline in HbA1c
timeFrame: 12 months
measure: Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
timeFrame: 3 months
measure: Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
timeFrame: 6 months
measure: Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
timeFrame: 9 months
measure: Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
timeFrame: 12 months
measure: Glucose management indicator
timeFrame: 3 months
measure: Glucose management indicator
timeFrame: 6 months
measure: Glucose management indicator
timeFrame: 9 months
measure: Glucose management indicator
timeFrame: 12 months
measure: Percent time Sensor in hypoglycemia
timeFrame: 3 months
measure: Percent time Sensor in hypoglycemia
timeFrame: 6 months
measure: Percent time Sensor in hypoglycemia
timeFrame: 9 months
measure: Percent time Sensor in hypoglycemia
timeFrame: 12 months
measure: Percent time Sensor in hyperglycemia
timeFrame: 3 months
measure: Percent time Sensor in hyperglycemia
timeFrame: 6 months
measure: Percent time Sensor in hyperglycemia
timeFrame: 9 months
measure: Percent time Sensor in hyperglycemia
timeFrame: 12 months
measure: Change from baseline in Diabetes Distress Scale
timeFrame: 3 months
measure: Change from baseline in Diabetes Distress Scale
timeFrame: 6 months
measure: Change from baseline in Diabetes Distress Scale
timeFrame: 9 months
measure: Change from baseline in Diabetes Distress Scale
timeFrame: 12 months
measure: Change from baseline in Hypoglycemia Confidence Scale
timeFrame: 3 months
measure: Change from baseline in Hypoglycemia Confidence Scale
timeFrame: 6 months
measure: Change from baseline in Hypoglycemia Confidence Scale
timeFrame: 9 months
measure: Change from baseline in Hypoglycemia Confidence Scale
timeFrame: 12 months
measure: Change from baseline in Insulin Delivery Satisfaction Survey
timeFrame: 3 months
measure: Change from baseline in Insulin Delivery Satisfaction Survey
timeFrame: 6 months
measure: Change from baseline in Insulin Delivery Satisfaction Survey
timeFrame: 9 months
measure: Change from baseline in Insulin Delivery Satisfaction Survey
timeFrame: 12 months
measure: System Usability Scale
timeFrame: 3 months
measure: System Usability Scale
timeFrame: 6 months
measure: System Usability Scale
timeFrame: 9 months
measure: System Usability Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milpitas
country: United States
facility: Bigfoot Biomedical Inc.
state: California
Study officials:
affiliation: Bigfoot Biomedical
name: Jim Malone, MD
role: PRINCIPAL_INVESTIGATOR
References: