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Behavioural Intervention
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 180, 365
Awards & highlights
ACTION-DM Trial 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.Check my eligibility
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.See study design
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.
ACTION-DM Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in HbA1c
Significant change in HbA1c
ACTION-DM 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.
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Who is running the clinical trial?
Better TherapeuticsLead Sponsor
4 Previous Clinical Trials
1,266 Total Patients Enrolled
Mass General BrighamUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your average blood sugar level, measured over the past few months, is higher than 7.01%.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.My doctor expects I have less than a year to live due to my condition.I am willing to regularly check my blood sugar levels for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Intervention BT-001 + Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could any prospective participants currently join this research endeavor?
"As per the information found on clinicaltrials.gov, this medical trial has ceased its search for participants since it was last updated in April of 2022. However, there are still 1,394 other experiments actively recruiting volunteers."
Answered by AI
What specific criteria must a participant meet in order to be eligible for this clinical trial?
"To qualify for this trial, applicants must have type 2 diabetes mellitus and should be between 18-75 years old. 500 participants are needed in total."
Answered by AI
Is this exploration open to participants aged 20 and over?
"To take part in this study, individuals must be between the ages of 18 and 75. For those under 18 years old there are 193 clinical trials available while patients over 65 have access to 1067 studies."
Answered by AI
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