Diabetes Type 2ACTION-DMNCT05302050
A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
A study testing BT-001 in people with Diabetes Type 2, run by Better Therapeutics at 1 site in United States.
Trial summary
Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- BT-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 1 Dec 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
- Current (within 3 months prior to enrollment) HbA1c >=7.01%
- Possession of and ability to use Android or iPhone mobile phone
- Speaks and reads in English
- Willing to measure frequent fasting finger glucose measurements as part of the App utilization
Who cannot join
- Current use of insulin other than a long-acting insulin analogue or human NPH insulin
- HbA1c >=11%
- Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
- Any terminal medical condition with life expectancy of < 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mass General Brigham Hospital and Clinics
Boston, Massachusetts, 02199
About this study
Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.
Read the detailed description
The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section
- Conditions
- Diabetes Type 2
- Being tested
- BT-001, Control Mobile Application
- 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-001Device
BT-001is 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 Mobile ApplicationDevice
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 | Active comparator | Patients in this arm will receive the BT-001 treatment for up to 18 months. Receives: Device: BT-001 |
| Standard of Care | Other | Patients will have access to a control mobile application for 6 months and then will have the option to use the treatment for the remainder of the 18 month study Receives: Device: Control Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.
Measured: Baseline and Day 180
Secondary outcomes (2)
Change in HbA1c
Change in HbA1c from baseline (enrollment) and from 6 months, to 12 months after enrollment between groups
Measured: Baseline and day 180, 365
Significant change in HbA1c
Proportion of patients with a ≥ 0.4% decrease in HbA1c at 12 months within each study group
Measured: Baseline and Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Mar 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes 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
- The study population consists of approximately 500 total participants, ages 18 - 75 years old, inclusive, who have type 2 diabetes. They will be randomized to the treatment or control group at a 3:1 ratio
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Better Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302050
- Sponsor's protocol ID
- DM2-07-MGB
- Acronym
- ACTION-DM
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 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: IPD will not be shared
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
- A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05302050
- Acronym / sponsor ID
- ACTION-DM / DM2-07-MGB
- Conditions
- Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Better TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 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, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.
Detailed description
The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population consists of approximately 500 total participants, ages 18 - 75 years old, inclusive, who have type 2 diabetes. They will be randomized to the treatment or control group at a 3:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Intervention BT-001 + Standard of Care | Active comparator | Device: BT-001Patients in this arm will receive the BT-001 treatment for up to 18 months. |
| Standard of Care | Other | Device: Control Mobile ApplicationPatients will have access to a control mobile application for 6 months and then will have the option to use the treatment for the remainder of the 18 month 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)
- Current (within 3 months prior to enrollment) HbA1c >=7.01%
- Possession of and ability to use Android or iPhone mobile phone
- Speaks and reads in English
- Willing to measure frequent fasting finger glucose measurements as part of the App utilization
Key exclusion criteria (4 listed)
- Current use of insulin other than a long-acting insulin analogue or human NPH insulin
- HbA1c >=11%
- Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
- Any terminal medical condition with life expectancy of < 1 year.
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-001is 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. | Device | Intervention BT-001 + Standard of Care |
| Control Mobile ApplicationThe app asks patients brief questions about their health but does not include any behavioral therapy. | Device | Standard of Care |
Primary outcome
Change in HbA1c
Time frame: Baseline and Day 180
Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.
2 secondary outcomes
Change in HbA1c
Time frame: Baseline and day 180, 365
Significant change in HbA1c
Time frame: Baseline and Day 365
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. IPD will not be shared
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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.
1 site 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 Type 2, run by Better Therapeutics 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 4 inclusion and 4 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 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 in HbA1c (time frame: Baseline and Day 180). 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.