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

NCT05094401 | Terminated Phase 3 DMC

• 1 other identifier: DM2-07-CAT
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean change in HbA1c

  Mean change in HbA1c from baseline (enrollment) to 12 months after enrollment

  Baseline and Day 365

Secondary Outcomes (1)

• Change in Medications

  Baseline and Day 365

Study Arms (1)

Intervention BT-001 + Standard of Care

EXPERIMENTAL

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

Interventions

BT-001 DEVICE

BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.

Intervention BT-001 + Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Better Therapeutics: lead
• Catalyst Health Network: collaborator

Study Sites (1)

Catalyst Health Network

Plano, Texas, 75024, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Pragmatic

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: October 4, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)