Diabetes Mellitus, Type 2BRIGHTNCT05266625
Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy
A study testing BT-001 in people with Diabetes Mellitus, Type 2, run by Better Therapeutics at 3 sites in United States.
Trial summary
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BT-001
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2022to Nov 2025
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, inclusive at the time of signing the informed consent
- Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months
- HbA1c 7.0% to 10.9% (within thirty [30] days of signing the informed consent form [ICF])
- Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.
Who cannot join
- Current use of outpatient prandial insulin
- In the opinion of the investigator, life expectancy < one (1) year
- COVID-19 diagnosis within thirty (30) days prior to randomization.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Hospital
Aurora, Colorado, 80045
VA Medical Center-Durham
Durham, North Carolina, 27705
Ascension DePaul Community Health
New Orleans, Louisiana, 70118
About this study
Official title: Randomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
Read the detailed description
This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BT-001, Control App
- 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.
BT-001Behavioural
Bt-001 is a software application that delivers treatment to participants with type 2 diabetes, using behavioral therapy. BT-001 is accessed via the participants' smartphone.
The behavioral intervention process involves:
Identifying maladaptive thoughts based on misinformed core beliefs that lead to disease-promoting behaviors; replacing maladaptive core beliefs with adaptive ways of thinking; and providing collaborative construction of behavioral exercises to test core beliefs.
Each week, Bt-001 asks participants to complete a new lesson, along with one skill exercise. The lessons are expected to take between 10-20 minutes to complete. In addition to completing a lesson and skill, participants will be directed to report plant-based meals consumed and minutes of exercise completed and to measure their blood sugar daily.
Control AppOther
The app asks patients brief questions about their health but does not include any behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention BT-001 + Standard of Care | Experimental | Patients in this arm will receive the BT-001 treatment for up to 720 days. Receives: Behavioral: BT-001 |
| Standard of Care | Other | Patients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study Receives: Other: Control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Difference in the mean change from baseline in HbA1c between treatment groups.
Measured: 90 days
Adverse Events
Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups
Measured: 90 days
Secondary outcomes (2)
Difference in HbA1c
Difference in mean change from baseline in HbA1c between treatment groups.
Measured: 180 days
Adverse Events
Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start14 Feb 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to an intervention arm or control arm. After 6 months, patients in the control arm will be able to cross over to using the intervention.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Better Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CPC Clinical Research, University of Colorado, Denver, Ascension Health, Department of Veterans Affairs Hospital Durham, NC, University of Colorado Health Clinics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266625
- Sponsor's protocol ID
- DM2-07-CPC
- Acronym
- BRIGHT
- Status last verified
- Oct 2023
- First submitted
- 23 Feb 2022
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting
- ClinicalTrials.gov ID
- NCT05266625
- Acronym / sponsor ID
- BRIGHT / DM2-07-CPC
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Better TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- CPC Clinical Research, University of Colorado, Denver, Ascension Health, Department of Veterans Affairs Hospital Durham, NC, University of Colorado Health Clinics
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Mar 2022 (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.
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
Detailed description
This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to an intervention arm or control arm. After 6 months, patients in the control arm will be able to cross over to using the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention BT-001 + Standard of Care | Experimental | Behavioral: BT-001Patients in this arm will receive the BT-001 treatment for up to 720 days. |
| Standard of Care | Other | Other: Control AppPatients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years, inclusive at the time of signing the informed consent
- Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months
- HbA1c 7.0% to 10.9% (within thirty [30] days of signing the informed consent form [ICF])
- Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.
Key exclusion criteria (3 listed)
- Current use of outpatient prandial insulin
- In the opinion of the investigator, life expectancy < one (1) year
- COVID-19 diagnosis within thirty (30) days prior to randomization.
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 |
|---|---|---|
| BT-001Bt-001 is a software application that delivers treatment to participants with type 2 diabetes, using behavioral therapy. BT-001 is accessed via the participants' smartphone. The behavioral intervention process involves: Identifying maladaptive thoughts based on misinformed core beliefs that lead to disease-promoting behaviors; replacing maladaptive core beliefs with adaptive ways of thinking; and providing collaborative construction of behavioral exercises to test core beliefs. Each week, Bt-001 asks participants to complete a new lesson, along with one skill exercise. The lessons are expected to take between 10-20 minutes to complete. In addition to completing a lesson and skill, participants will be directed to report plant-based meals consumed and minutes of exercise completed and to measure their blood sugar daily. | Behavioural | Intervention BT-001 + Standard of Care |
| Control AppThe app asks patients brief questions about their health but does not include any behavioral therapy. | Other | Standard of Care |
Primary outcome
Change in HbA1c
Time frame: 90 days
Difference in the mean change from baseline in HbA1c between treatment groups.
Adverse Events
Time frame: 90 days
Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups
2 secondary outcomes
Difference in HbA1c
Time frame: 180 days
Adverse Events
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BT-001 in people with Diabetes Mellitus, Type 2, run by Better Therapeutics at 3 sites 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 4 inclusion and 3 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 in HbA1c (time frame: 90 days). The study lists 2 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 30 Oct 2023.