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

N/A

Waitlist Available

Research Sponsored by Better Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Current use of insulin other than a long-acting insulin analogue or human NPH insulin

Any terminal medical condition with life expectancy of < 1 year.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and day 180, 365

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since BT-001 is a digital therapeutic intervention focused on behavior change rather than medication, it may not have traditional side effects but could include stress due to frequent monitoring or frustration if technical issues occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My doctor expects I have less than a year to live due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and day 180, 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and day 180, 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 180, 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in HbA1c

Significant change in HbA1c

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met