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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Better Therapeutics

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

+1 more

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.

+1 more

Participant Groups

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.

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.