Type 1 or Type 2 DiabetesBURSTNCT05088265
Bigfoot Unity Real World Study
An observational study of Type 1 or Type 2 Diabetes, run by Bigfoot Biomedical Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 or Type 2 Diabetes
- What is being tested?
- Bigfoot Unity Diabetes Management System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Type 1 or Type 2 Diabetes
- Being tested
- Bigfoot Unity Diabetes Management System
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bigfoot Unity Diabetes Management SystemDevice
The Bigfoot Unity System is a wirelessly connected set of hardware and software that is intended for use by people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. Bigfoot Unity consists of the Abbott FreeStyle Libre 2 Sensor, two durable insulin pen caps (one each for specific rapid-acting and long-acting insulin pens) and an iOS-specific mobile App.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Glycated hemoglobin
Measured: 3 months
Change from baseline in HbA1c
Glycated hemoglobin
Measured: 6 months
Change from baseline in HbA1c
Glycated hemoglobin
Measured: 9 months
Change from baseline in HbA1c
Glycated hemoglobin
Measured: 12 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Measured: 3 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Measured: 6 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Measured: 9 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Measured: 12 months
Glucose management indicator
Measured: 3 months
Glucose management indicator
Measured: 6 months
Glucose management indicator
Measured: 9 months
Glucose management indicator
Measured: 12 months
Percent time Sensor in hypoglycemia
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Measured: 3 months
Percent time Sensor in hypoglycemia
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Measured: 6 months
Percent time Sensor in hypoglycemia
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Measured: 9 months
Percent time Sensor in hypoglycemia
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Measured: 12 months
Percent time Sensor in hyperglycemia
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Measured: 3 months
Percent time Sensor in hyperglycemia
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Measured: 6 months
Percent time Sensor in hyperglycemia
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Measured: 9 months
Percent time Sensor in hyperglycemia
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Measured: 12 months
Change from baseline in Diabetes Distress Scale
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
Measured: 3 months
Change from baseline in Diabetes Distress Scale
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
Measured: 6 months
Change from baseline in Diabetes Distress Scale
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
Measured: 9 months
Change from baseline in Diabetes Distress Scale
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
Measured: 12 months
Change from baseline in Hypoglycemia Confidence Scale
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.
Measured: 3 months
Change from baseline in Hypoglycemia Confidence Scale
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.
Measured: 6 months
Change from baseline in Hypoglycemia Confidence Scale
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.
Measured: 9 months
Change from baseline in Hypoglycemia Confidence Scale
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.
Measured: 12 months
Change from baseline in Insulin Delivery Satisfaction Survey
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
Measured: 3 months
Change from baseline in Insulin Delivery Satisfaction Survey
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
Measured: 6 months
Change from baseline in Insulin Delivery Satisfaction Survey
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
Measured: 9 months
Change from baseline in Insulin Delivery Satisfaction Survey
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
Measured: 12 months
System Usability Scale
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Measured: 3 months
System Usability Scale
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Measured: 6 months
System Usability Scale
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Measured: 9 months
System Usability Scale
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start26 Oct 2021
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 or Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bigfoot Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Jim Malone, MD, Principal investigator, Bigfoot Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088265
- Sponsor's protocol ID
- 21BF01
- Acronym
- BURST
- Status last verified
- Feb 2023
- First submitted
- 8 Oct 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System
- ClinicalTrials.gov ID
- NCT05088265
- Acronym / sponsor ID
- BURST / 21BF01
- Conditions
- Type 1 or Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bigfoot Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bigfoot Unity Diabetes Management SystemThe Bigfoot Unity System is a wirelessly connected set of hardware and software that is intended for use by people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. Bigfoot Unity consists of the Abbott FreeStyle Libre 2 Sensor, two durable insulin pen caps (one each for specific rapid-acting and long-acting insulin pens) and an iOS-specific mobile App. | Device | – |
Primary outcome
Change from baseline in HbA1c
Time frame: 3 months
Glycated hemoglobin
Change from baseline in HbA1c
Time frame: 6 months
Glycated hemoglobin
Change from baseline in HbA1c
Time frame: 9 months
Glycated hemoglobin
Change from baseline in HbA1c
Time frame: 12 months
Glycated hemoglobin
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time frame: 3 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time frame: 6 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time frame: 9 months
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
Time frame: 12 months
Glucose management indicator
Time frame: 3 months
Glucose management indicator
Time frame: 6 months
Glucose management indicator
Time frame: 9 months
Glucose management indicator
Time frame: 12 months
Percent time Sensor in hypoglycemia
Time frame: 3 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Percent time Sensor in hypoglycemia
Time frame: 6 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Percent time Sensor in hypoglycemia
Time frame: 9 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Percent time Sensor in hypoglycemia
Time frame: 12 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Percent time Sensor in hyperglycemia
Time frame: 3 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Percent time Sensor in hyperglycemia
Time frame: 6 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Percent time Sensor in hyperglycemia
Time frame: 9 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Percent time Sensor in hyperglycemia
Time frame: 12 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
System Usability Scale
Time frame: 3 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
System Usability Scale
Time frame: 6 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
System Usability Scale
Time frame: 9 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
System Usability Scale
Time frame: 12 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Malone, MD principal investigator
Bigfoot Biomedical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 or Type 2 Diabetes, run by Bigfoot Biomedical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c (time frame: 3 months). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.