CLINICAL TRIAL

Treatment for Diabetes Mellitus, Type 2

EnrollingByInvitation · 18+ · All Sexes · Boston, MA

A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

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About the trial for Diabetes Mellitus, Type 2

Eligible Conditions
Diabetes Mellitus, Type 2 · Diabetes Mellitus · Diabetes Type 2

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
BT-001
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Current (within 3 months prior to enrollment) HbA1c >=7.01%
Possession of and ability to use Android or iPhone mobile phone
Speaks and reads in English
Willing to measure frequent fasting finger glucose measurements as part of the App utilization
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and day 180, 365
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and day 180, 365.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Baseline and Day 365.

Significant change in HbA1c
BASELINE AND DAY 365
Proportion of patients with a ≥ 0.4% decrease in HbA1c at 12 months within each study group
Change in HbA1c
BASELINE AND DAY 180, 365
Change in HbA1c from baseline (enrollment) and from 6 months, to 12 months after enrollment between groups

Patient Q & A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus, Type 2 by sharing your contact details with the study coordinator.