Type 2 DiabetesPhase 3NCT04886388
Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
A Phase 3 study testing BT-001 in people with Type 2 Diabetes, run by Better Therapeutics at 6 sites in United States.
Trial summary
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 668 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Apr 2021to 27 Sep 2022
- Phase
- Phase 3
- 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
- Between 18 and 75 years old, inclusive at the time of signing the informed consent;
- Diagnosis of type 2 diabetes, according to the criteria of the American Diabetes Association (ADA), and confirmed at the initial eligibility screening;
- Body Mass Index ≥25 kg/m2;
- Possesses a smartphone (iPhone or Android only) capable of running the smartphone applications (Apps) used in the study;
- Has had no change in the last 4 months prior to randomization (3 months prior to initial screening plus 30-day run-in screening period) in antihyperglycemic medications;
- Has a current HbA1c level >7%, as determined by both screening assessments;
- Willing to use an FDA approved glucometer for self-monitoring blood glucose throughout the study;
- Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Who cannot join
- Are unable to understand, consent to, or comply with the study protocol for any reason;
- Currently taking prandial (mealtime) insulin;
- Have self-reported measures, collected during screening interview, that reveal:
- An active eating disorder
- The taking of or planning to take (within the next 6 months):
- Oral steroids (planned, or within the past 3 months) ii. Chemotherapy (planned, or within the past 6 months) iii. Weight loss medications or iv. Atypical antipsychotic medications
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- A change in antidepressant or anti-anxiety medication within the past 3 months;
- A history of bariatric surgery or planned bariatric surgery during the study;
- The current use of marijuana, cocaine, opioid painkillers, or other addictive substances;
- The current use of tobacco products or use of tobacco products within the past 6 months;
- The consumption of alcohol above defined thresholds:
- For women: more than 3 drinks in a single day, or more than 7 drinks per week and ii. For men: more than 4 drinks in a single day, or more than 14 drinks per week
- An unstable or life-threatening medical illness;
- Non-resolved, presumed or confirmed COVID-19 diagnosis prior to randomization or during primary study period;
- For women only: pregnant (or lactating) or having the intention of becoming pregnant during the time frame of the study.
- Has a current HbA1c level ≥11%, at the screening assessment;
- Concurrent enrollment in any other clinical trial;
- Is considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study Site
Atlanta, Georgia, 30301
Study Site
Chicago, Illinois, 60007
Study Site
Houston, Texas, 77001
Study Site
Miami, Florida, 33101
Study Site
New York, New York, 10001
Study Site
San Francisco, California, 94110
About this study
Official title: Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) compared to standard medical care in patients with type 2 diabetes.
Read the detailed description
The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC alone in patients with type 2 diabetes. The screening period will consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility.
Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups:
Investigational: One half of the participants will be treated with BT-001 plus SOC for 180 days;
Control: One half of the participants will be treated with SOC alone for 180 days.
- Conditions
- Type 2 Diabetes
- Being tested
- BT-001, Physician-guided Standard of Care for type 2 diabetes
- 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-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
Physician-guided Standard of Care for type 2 diabetesOther
Current ADA Standard of Care Guidelines for type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| BT-001 + Standard of Care | Experimental | BT-001 is a software program used with physician guidance, being investigated to improve glycemic control. Patients randomized to this arm of the study will interact with the BT-001 software program in addition to receiving Standard of Care for type 2 diabetes Receives: Device: BT-001; Other: Physician-guided Standard of Care for type 2 diabetes |
| Standard of Care | Active comparator | Patients randomized to the Standard of Care arm will receive Standard of Care treatment for type 2 diabetes under the guidance of a physician Receives: Other: Physician-guided Standard of Care for type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the mean change from baseline in HbA1c at Day 90 between Intervention and Standard of Care groups
Hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.
Measured: Baseline and Day 90
Secondary outcomes (1)
The difference in the mean change from baseline in HbA1c at Day 180 between Intervention and Standard of Care groups
Hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.
Measured: Baseline and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start22 Apr 2021
- Primary completion9 Mar 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label, Randomized, Controlled
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Better Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Berman, MD, Study director, Better Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886388
- Sponsor's protocol ID
- DM2-06
- Status last verified
- Jan 2022
- First submitted
- 7 May 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04886388
- Acronym / sponsor ID
- DM2-06
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Better TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 14 May 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.
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) compared to standard medical care in patients with type 2 diabetes.
Detailed description
The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC alone in patients with type 2 diabetes. The screening period will consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility.
Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups:
Investigational: One half of the participants will be treated with BT-001 plus SOC for 180 days;
Control: One half of the participants will be treated with SOC alone for 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-Label, Randomized, Controlled
| Arm | Type | Receives |
|---|---|---|
| BT-001 + Standard of Care | Experimental | Device: BT-001, Other: Physician-guided Standard of Care for type 2 diabetesBT-001 is a software program used with physician guidance, being investigated to improve glycemic control. Patients randomized to this arm of the study will interact with the BT-001 software program in addition to receiving Standard of Care for type 2 diabetes |
| Standard of Care | Active comparator | Other: Physician-guided Standard of Care for type 2 diabetesPatients randomized to the Standard of Care arm will receive Standard of Care treatment for type 2 diabetes under the guidance of a physician |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 18 and 75 years old, inclusive at the time of signing the informed consent;
- Diagnosis of type 2 diabetes, according to the criteria of the American Diabetes Association (ADA), and confirmed at the initial eligibility screening;
- Body Mass Index ≥25 kg/m2;
- Possesses a smartphone (iPhone or Android only) capable of running the smartphone applications (Apps) used in the study;
- Has had no change in the last 4 months prior to randomization (3 months prior to initial screening plus 30-day run-in screening period) in antihyperglycemic medications;
Key exclusion criteria (18 listed)
- Are unable to understand, consent to, or comply with the study protocol for any reason;
- Currently taking prandial (mealtime) insulin;
- Have self-reported measures, collected during screening interview, that reveal:
- Has a current HbA1c level ≥11%, at the screening assessment;
- Concurrent enrollment in any other clinical trial;
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 program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control. | Device | BT-001 + Standard of Care |
| Physician-guided Standard of Care for type 2 diabetesCurrent ADA Standard of Care Guidelines for type 2 diabetes | Other | BT-001 + Standard of Care, Standard of Care |
Primary outcome
The difference in the mean change from baseline in HbA1c at Day 90 between Intervention and Standard of Care groups
Time frame: Baseline and Day 90
Hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.
1 secondary outcome
The difference in the mean change from baseline in HbA1c at Day 180 between Intervention and Standard of Care groups
Time frame: Baseline and Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
Mark Berman, MD study director
Better Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BT-001 in people with Type 2 Diabetes, run by Better Therapeutics at 6 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in the mean change from baseline in HbA1c at Day 90 between Intervention and Standard of Care groups (time frame: Baseline and Day 90). 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 28 Sep 2023.