Catalyst has started participating with the Better Therapeutics Study to bring your diabetic patients a new solution for better glycemic control. We are excited to offer this enhancement to our existing Diabetes Care pathway and look forward to seeing the impact it will have.
What is Better Therapeutics?
Better Therapeutics is a research study looking at the long-term effectiveness and total cost of care impact after real-world use of an investigational digital therapeutic in patients with type 2 diabetes.
The study uses a mobile application, BT-001, which is designed to deliver a novel form of behavioral therapy to help patients with type 2 diabetes improve glycemic control, while under the guidance of a physician.
What is the goal of Better Therapeutics?
The main goals and objectives of this study are:
Improve outcomes in patients with type 2 diabetes by addressing root cause behaviors
Sustain improved clinical effectiveness and durability of outcomes over 1-year
Improve overall total cost of care by reducing rates over time of:
Prescription drug use
Hospitalizations
Emergency Department visits
Understand real world usage patterns of the BT-001 application in primary care
Catalyst is hoping to enroll at least 250 patients in the Better Therapeutics Study by October 2022 and plans to have all patients complete the 12-month program by October 2023.
What does Better Therapeutics offer to patients?
Secure App
Tracking of health values and behaviors
Evidence-based approach of cognitive exercises
Continuation of current treatment and medical visits with PCP
Personalized feedback
$300 incentive
Which patients are eligible for the Better Therapeutics Study?
Exclusions
Individuals will not be eligible to participate if they meet any of the following criteria:
Unable to understand, consent to, or comply with the study protocol for any reason, including the inability to read or comprehend English. The behavioral intervention mechanisms, including educational materials and digital tools, are only available in English at this time.
Currently taking prandial (mealtime) insulin.
Currently experiencing heart failure of NYHA Class IV
Currently experiencing stage 4 or 5 chronic kidney disease.
Currently on kidney dialysis (hemo or peritoneal).
Currently on the list for an organ transplant or previously received a transplant of any organ.
Currently receiving treatment for cancer.
For women only: pregnant or lactating or intend to become pregnant during the study (October 2022 - October 2023).
Presumed or confirmed COVID-19 diagnosis within 90 days prior to study enrollment.
Concurrent enrollment in any other interventional clinical trial.
Is considered unreliable by the investigator, or has any condition that, in the opinion of the investigator, would not allow safe participation in the study.
Inclusions
Male and female participants who meet the following criteria are eligible to participate in the study:
Between 18 and 75 years old, inclusive, at the time of signing the informed consent form (“ICF”).
Diagnosis of type 2 diabetes.
Possess a smartphone (iPhone or Android only) capable of running the smartphone application (“App”) used in the study.
HbA1c level ≥7% and <11%, as determined by the HbA1c measured within the previous 12 months.
Willing to use a glucometer for self-monitoring blood glucose while using the study App.
Capable of giving informed consent in English, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
How are patients enrolled in Better Therapeutics?
The Catalyst Care Team will offer the study to eligible patients currently enrolled in Catalyst Care Management services. The Catalyst Care Team will also be conducting outreach to patients identified through a cohort to enroll in the study alongside Care Management services.
PCPs who identify an eligible patient may refer the patient to the Care Team via the current Leading Reach “Comprehensive Care Support” referral process and add a note that the patient would be a candidate for “Better Therapeutics”. The Care Team will assist in connecting the patient to the study.