Bigfoot Unity Real World Study (BURST)

February 16, 2023 updated by: Bigfoot Biomedical Inc.

Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Milpitas, California, United States, 95035
        • Bigfoot Biomedical Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in HbA1c
Time Frame: 6 months
Glycated hemoglobin
6 months
Change from baseline in HbA1c
Time Frame: 3 months
Glycated hemoglobin
3 months
Change from baseline in Hypoglycemia Confidence Scale
Time Frame: 6 months
Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse.
6 months
Change from baseline in Hypoglycemia Confidence Scale
Time Frame: 3 months
Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse.
3 months
Change from baseline in Insulin Delivery Satisfaction Survey
Time Frame: 6 months
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
6 months
Change from baseline in Insulin Delivery Satisfaction Survey
Time Frame: 3 months
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
3 months
System Usability Scale
Time Frame: 6 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
6 months
System Usability Scale
Time Frame: 3 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
3 months
Change from baseline in HbA1c
Time Frame: 9 months
Glycated hemoglobin
9 months
Change from baseline in HbA1c
Time Frame: 12 months
Glycated hemoglobin
12 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time Frame: 3 months
3 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time Frame: 6 months
6 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time Frame: 9 months
9 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time Frame: 12 months
12 months
Glucose management indicator
Time Frame: 3 months
3 months
Glucose management indicator
Time Frame: 6 months
6 months
Glucose management indicator
Time Frame: 9 months
9 months
Glucose management indicator
Time Frame: 12 months
12 months
Percent time Sensor in hypoglycemia
Time Frame: 3 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
3 months
Percent time Sensor in hypoglycemia
Time Frame: 6 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
6 months
Percent time Sensor in hypoglycemia
Time Frame: 9 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
9 months
Percent time Sensor in hypoglycemia
Time Frame: 12 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
12 months
Percent time Sensor in hyperglycemia
Time Frame: 3 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
3 months
Percent time Sensor in hyperglycemia
Time Frame: 6 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
6 months
Percent time Sensor in hyperglycemia
Time Frame: 9 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
9 months
Percent time Sensor in hyperglycemia
Time Frame: 12 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
12 months
Change from baseline in Diabetes Distress Scale
Time Frame: 3 months
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
3 months
Change from baseline in Diabetes Distress Scale
Time Frame: 6 months
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
6 months
Change from baseline in Diabetes Distress Scale
Time Frame: 9 months
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
9 months
Change from baseline in Diabetes Distress Scale
Time Frame: 12 months
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
12 months
Change from baseline in Hypoglycemia Confidence Scale
Time Frame: 9 months
Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse.
9 months
Change from baseline in Hypoglycemia Confidence Scale
Time Frame: 12 months
Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse.
12 months
Change from baseline in Insulin Delivery Satisfaction Survey
Time Frame: 9 months
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
9 months
Change from baseline in Insulin Delivery Satisfaction Survey
Time Frame: 12 months
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
12 months
System Usability Scale
Time Frame: 9 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
9 months
System Usability Scale
Time Frame: 12 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bigfoot Biomedical Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jaeb Center for Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21BF01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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