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

Long-term Effectiveness and Medication Changes After Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes Cared for in a Community Based, Clinically Integrated Network

BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) in patients with type 2 diabetes.

Study Overview

• Status: Terminated
• Conditions: Type2 Diabetes
• Intervention / Treatment: Device: BT-001

Detailed Description

The study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) in patients with type 2 diabetes. The screening period will consist of review of Electronic Health Record (EHR) for participants that meet inclusion criteria and telephonic outreach.

Once confirmed consented, patients will then be given access to BT-001 for 90 days with an opportunity to continue using the product for an additional 275 days.

Participants will continue their standard of care with their provider in addition to using BT-001.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75024
      • Catalyst Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 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 informed consent form (ICF) and in this protocol.

Exclusion 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 New York Heart Association 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 having the intention of becoming pregnant during the time frame of the study;
• Presumed or confirmed COVID-19 diagnosis within 90 days prior to study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention BT-001 + Standard of Care; 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	Device: BT-001; BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in HbA1c	Mean change in HbA1c from baseline (enrollment) to 12 months after enrollment	Baseline and Day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medications	The change in number and type of medications used to treat type 2 diabetes, hypertension and dyslipidemia from baseline to 12 months	Baseline and Day 365

Collaborators and Investigators

• Sponsor: Better Therapeutics
• Collaborators: Catalyst Health Network

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DM2-07-CAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No