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Behavioural Intervention

BT-001 for Type 2 Diabetes

Phase 3

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and day 365

Awards & highlights

Study Summary

This trial is testing a software program, BT-001, to see if it can help patients with type 2 diabetes improve their glycemic control by changing behaviors related to blood sugar levels.

Eligible Conditions

Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and day 365

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in HbA1c

Secondary outcome measures

Change in Medications

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention BT-001 + Standard of CareExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BT-001

2021

Completed Phase 3

~670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Better TherapeuticsLead Sponsor

4 Previous Clinical Trials

1,690 Total Patients Enrolled

Catalyst Health NetworkUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To date, how many people have signed up to be a part of this clinical trial?

"Yes, this is an active trial that was posted on October 4th 2021 and updated 10 days later. They are looking for 250 patients from 1 site."

Answered by AI

Does this trial have an age limit?

"The age limit for this clinical trial is 75 years old, and patients must be above the age of 18."

Answered by AI

Can people with the relevant medical condition participate in this trial at present?

"The study is recruiting patients, as noted on clinicaltrials.gov. The listing for the trial was first posted on October 4th 2021 and has since been edited."

Answered by AI

Has BT-001 received FDA marketing authorization?

"BT-001's safety is rated highly by our team at Power. This is due to the fact that BT-001 is in Phase 3 trials, which means that not only does some data support efficacy, but multiple rounds of data also support safety."

Answered by AI

Who does this research project accept as participants?

"This clinical trial is recruiting 250 participants with diabetes mellitus aged 18 and 75. Most notably, applicants are required to meet the following criteria: 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., 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"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes

2021. "Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05094401.