Digital Therapy for Type 2 Diabetes

(ACTION-DM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Better Therapeutics

Must not be taking: Insulin

Disqualifiers: Cognitive impairment, Terminal condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital treatment called BT-001, designed to help people manage type 2 diabetes by better controlling their blood sugar levels. Participants will use either a standard health app or the BT-001 app, which aims to simplify and enhance diabetes management. Ideal participants have type 2 diabetes with a recent HbA1c (a measure of blood sugar) of 7% or higher, use a smartphone, and are willing to regularly check their blood sugar levels. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain types of insulin. It's best to discuss your specific medications with the trial team.

What prior data suggests that this digital therapy is safe for type 2 diabetes?

Research shows that BT-001 is a digital therapy designed to help manage type 2 diabetes. It uses a smartphone app to deliver cognitive behavioral therapy (CBT), which helps change behaviors to better control blood sugar levels.

Although specific safety data for BT-001 is not yet available, digital therapies are generally considered safe. This therapy uses an app to provide CBT, avoiding the side effects often associated with medication.

Even without detailed data, BT-001 is being tested in a trial because earlier studies have shown it is safe enough for use. If any concerns arise, the trial team will closely monitor participants for any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Type 2 diabetes, which often include medications like metformin or insulin, BT-001 is a digital therapy that leverages technology to help manage the condition. Researchers are excited about BT-001 because it offers a new way to engage patients through a mobile application, providing personalized recommendations and support directly on their devices. This approach is not only more convenient but also aims to empower patients to take an active role in managing their health, potentially leading to better outcomes and improved adherence to treatment plans.

What evidence suggests that this digital therapy is effective for type 2 diabetes?

Research shows that the digital tool BT-001, available to participants in this trial, can aid people with type 2 diabetes by improving blood sugar control. One study found that using BT-001 led to a 0.4% reduction in HbA1c, a measure of blood sugar management, over 90 days. This improvement occurred with less need to increase medication compared to a group not using BT-001. The tool employs cognitive behavioral therapy (CBT) techniques through a mobile app to assist users in managing their diabetes. This digital method has demonstrated significant benefits in controlling blood sugar levels, suggesting it could be a valuable tool for those with type 2 diabetes. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who can use an Android or iPhone, speak and read English, are willing to check their blood sugar regularly using the app, and have a recent HbA1c level over 7.01%. It's not for those with severe memory loss conditions, terminal illnesses with less than a year of life expectancy, or those on certain insulin treatments.

Inclusion Criteria

Speaks and reads in English

Your average blood sugar level, measured over the past few months, is higher than 7.01%.

Possession of and ability to use Android or iPhone mobile phone

Exclusion Criteria

I am currently using insulin, but it's not long-acting or NPH type.

Your HbA1c level is 11% or higher.

Criterion: You have a condition that affects your memory or thinking ability, such as Alzheimer's, dementia, or schizophrenia, which may make it hard for you to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BT-001 digital therapeutic for glycemic control in type 2 diabetes

12 months

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension

Participants may opt into additional treatment cycles of BT-001

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• BT-001

Trial Overview

The study tests BT-001, a digital tool designed to help manage blood sugar levels in people with type 2 diabetes. Participants will be randomly assigned to either use this new app or a control mobile application and will be openly followed up after the initial phase.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 1 Intervention

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

Group II: Intervention BT-001 + Standard of Care Active Control 1 Intervention

Patients in this arm will receive the BT-001 treatment for up to 18 months.

Who Is Running the Clinical Trial?

Better Therapeutics

Lead Sponsor

Trials

5

Recruited

1,800+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Mass General Brigham

Collaborator

Trials

2

Recruited

830+

Published Research Related to This Trial

The 'Walk with you' application for titrating basal insulin in hospitalized patients with type-2 diabetes significantly reduced fasting blood glucose (FBG) levels and helped more patients reach target FBG levels within 3 days compared to the standard adjustment regimen.

The application was found to be safe, with no significant difference in the incidence of hypoglycemia between the application group and the control group, making it a user-friendly and effective tool for managing insulin doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a basal insulin dose management smartphone application for controlling fasting blood glucose in patients with type-2 diabetes mellitus: A single-centre, randomised clinical study. Luo, E., Wan, J., Su, M., et al.[2023]

The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.

Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9862458/

Randomized, Controlled Trial of a Digital Behavioral ...

The observed HbA1c reduction of 0.4% at 90 days with BT-001 can be assessed alongside randomized trials of in-person CBT for glycemic control. In a meta- ...

2.

jacc.org

jacc.org/doi/full/10.1016/S0735-1097(23)02251-9

DIGITAL COGNITIVE BEHAVIORAL THERAPY LEADS TO ...

CBT delivered via digital mobile app significantly reduced HbA1c compared to a control app despite less intensification of antihyperglycemic ...

3.

link.springer.com

link.springer.com/article/10.1007/s12325-023-02752-2

Cost-Effectiveness Analysis of a Prescription Digital ...

The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05266625?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Better%20Therapeutics%22)&viewType=Table&rank=3

Study Details | NCT05266625 | Digital Therapeutic Based ...

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 ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.038737

Digital Therapeutic Based Randomized Investigation to ...

Randomized, controlled trial of a novel digital therapeutic in patients with type 2 diabetes: BT‐001 pivotal trial 180 day outcomes. Diabetes ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN220058.pdf

DE Novo CLASSIFICATION REQUEST FOR BT-001

BT-001 is a digital diabetes device that delivers cognitive behavioral therapy (CBT) to a patient with Type 2 Diabetes through an application on ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/DEN220058.pdf

Diabetes digital behavioral therapeutic - accessdata.fda.gov

The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001.

8.

withpower.com

withpower.com/trial/digital-therapy-for-type-2-diabetes-add3d

Digital Therapy for Type 2 Diabetes (ACTION-DM Trial)

The research articles reviewed do not provide specific safety data for the digital therapy BT-001 or similar treatments. However, they suggest that ...