500 Participants Needed

Digital Therapy for Type 2 Diabetes

(ACTION-DM Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Better Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the digital therapy for type 2 diabetes, including BT-001, safe for humans?

The research articles reviewed do not provide specific safety data for the digital therapy BT-001 or similar treatments. However, they suggest that incretin-based therapies, which are used for type 2 diabetes, are generally well-tolerated and have a low risk profile compared to existing therapies.12345

How is the digital therapy BT-001 for type 2 diabetes different from other treatments?

BT-001 is a digital therapy that uses high-quality software to manage type 2 diabetes, offering a novel approach compared to traditional treatments. Unlike standard medications, it provides a patient-centric, software-driven intervention that can improve outcomes by integrating digital tools for precise glucose monitoring and facilitating communication between patients and healthcare providers.678910

What data supports the effectiveness of the treatment BT-001 for Type 2 Diabetes?

Research shows that digital therapies can help people with Type 2 Diabetes manage their condition by encouraging healthy lifestyle changes and regular monitoring of blood sugar levels. These digital solutions have been found to improve metabolic outcomes, which means they help control blood sugar and reduce complications.911121314

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

Your average blood sugar level, measured over the past few months, is higher than 7.01%.
Speaks and reads in English
Possession of and ability to use Android or iPhone mobile phone
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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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of CareExperimental Treatment1 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 CareActive Control1 Intervention
Patients in this arm will receive the BT-001 treatment for up to 18 months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Better Therapeutics

Lead Sponsor

Trials
5
Recruited
1,800+

Mass General Brigham

Collaborator

Trials
2
Recruited
830+

Published Research Related to This Trial

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.
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.
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]
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.
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]

Citations

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. [2023]
Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study. [2020]
Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. [2020]
Diabetes on demand and novel technologies. [2018]
Randomized forced titration to different doses of technosphere insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes. [2021]
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. [2023]
Device-supported automated basal insulin titration in adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. [2023]
Therapy in the early stage: incretins. [2021]
Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. [2022]
New treatments in type 2 diabetes: a focus on the incretin-based therapies. [2011]
Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Remote Monitoring of Diabetes: A Cloud-Connected Digital System for Individuals With Diabetes and Their Health Care Providers. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
A Review of Emerging Technologies in Diabetes Management for Multiple-Dose Insulin-Injecting Patients With Type 2 Diabetes Who Self-monitor Blood Glucose. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
3D Bioprinting and Translation of Beta Cell Replacement Therapies for Type 1 Diabetes. [2021]
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