Type2 DiabetesPhase 3NCT05094401
Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes
A Phase 3 study testing BT-001 in people with Type2 Diabetes, run by Better Therapeutics at 1 site 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
- Type2 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
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 1 Apr 2023
- 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
- Diagnosis of Type2 Diabetes
- Possess a smart phone (iPhone or Android only) capable of running the smart phone application (App) used in the study;
- HbA1c level ≥7% and <11%, as determined by the HbA1c measured within the previous 12 months;
- Willing to use a glucometer for self-monitoring blood glucose while using the study App;
- Capable of giving informed consent in English, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Unable to understand, consent to, or comply with the study protocol for any reason, including the inability to read or comprehend English. The behavioral intervention mechanisms, including educational materials and digital tools, are only available in English at this time;
- Currently taking prandial (mealtime) insulin;
- Currently experiencing heart failure of New York Heart Association Class IV;
- Currently experiencing stage 4 or 5 chronic kidney disease;
- Currently on kidney dialysis (hemo or peritoneal);
- Currently on the list for an organ transplant or previously received a transplant of any organ;
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- Currently receiving treatment for cancer;
- For women only: pregnant or lactating or having the intention of becoming pregnant during the time frame of the study;
- Presumed or confirmed COVID-19 diagnosis within 90 days prior to study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effectiveness and Medication Changes After Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes Cared for in a Community Based, Clinically Integrated Network
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) in patients with type 2 diabetes.
Read the detailed description
The study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) in patients with type 2 diabetes. The screening period will consist of review of Electronic Health Record (EHR) for participants that meet inclusion criteria and telephonic outreach.
Once confirmed consented, patients will then be given access to BT-001 for 90 days with an opportunity to continue using the product for an additional 275 days.
Participants will continue their standard of care with their provider in addition to using BT-001.
- Conditions
- Type2 Diabetes
- Being tested
- BT-001
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HbA1c
Mean change in HbA1c from baseline (enrollment) to 12 months after enrollment
Measured: Baseline and Day 365
Secondary outcomes (1)
Change in Medications
The change in number and type of medications used to treat type 2 diabetes, hypertension and dyslipidemia from baseline to 12 months
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 posted26 Oct 2021
- Study start4 Oct 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Why it stopped: Sponsor/Investigator Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Pragmatic
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Better Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Catalyst Health Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094401
- Sponsor's protocol ID
- DM2-07-CAT
- Status last verified
- Sep 2023
- First submitted
- 14 Oct 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
- Long-term Effectiveness and Medication Changes After Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes Cared for in a Community Based, Clinically Integrated Network
- ClinicalTrials.gov ID
- NCT05094401
- Acronym / sponsor ID
- DM2-07-CAT
- Conditions
- Type2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor/Investigator Decision
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Better TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Catalyst Health Network
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 26 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.
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) in patients with type 2 diabetes.
Detailed description
The study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) in patients with type 2 diabetes. The screening period will consist of review of Electronic Health Record (EHR) for participants that meet inclusion criteria and telephonic outreach.
Once confirmed consented, patients will then be given access to BT-001 for 90 days with an opportunity to continue using the product for an additional 275 days.
Participants will continue their standard of care with their provider in addition to using BT-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Pragmatic
| Arm | Type | Receives |
|---|---|---|
| Intervention BT-001 + Standard of Care | Experimental | Device: BT-001BT-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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Type2 Diabetes
- Possess a smart phone (iPhone or Android only) capable of running the smart phone application (App) used in the study;
- HbA1c level ≥7% and <11%, as determined by the HbA1c measured within the previous 12 months;
- Willing to use a glucometer for self-monitoring blood glucose while using the study App;
- Capable of giving informed consent in English, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (9 listed)
- Unable to understand, consent to, or comply with the study protocol for any reason, including the inability to read or comprehend English. The behavioral intervention mechanisms, including educational materials and digital tools, are only available in English at this time;
- Currently taking prandial (mealtime) insulin;
- Currently experiencing heart failure of New York Heart Association Class IV;
- Currently experiencing stage 4 or 5 chronic kidney disease;
- Currently on kidney dialysis (hemo or peritoneal);
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 | Intervention BT-001 + Standard of Care |
Primary outcome
Mean change in HbA1c
Time frame: Baseline and Day 365
Mean change in HbA1c from baseline (enrollment) to 12 months after enrollment
1 secondary outcome
Change in Medications
Time frame: Baseline and Day 365
Results and safety
The study was stopped early (reason given: Sponsor/Investigator Decision). Results are not available in the source record.
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.
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 Phase 3 study testing BT-001 in people with Type2 Diabetes, 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 5 inclusion and 9 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: stopped early, 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 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.
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 was stopped early (reason given: Sponsor/Investigator Decision). 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?
Mean change in HbA1c (time frame: Baseline and Day 365). 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.