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

Primary Purpose

Type2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BT-001
Sponsored by
Better Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catalyst Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention BT-001 + Standard of Care

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2021
Last Updated
September 26, 2023
Sponsor
Better Therapeutics
Collaborators
Catalyst Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT05094401
Brief Title
Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor/Investigator Decision
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Better Therapeutics
Collaborators
Catalyst Health Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-Label, Pragmatic
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention BT-001 + Standard of Care
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
BT-001
Intervention Description
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
Primary Outcome Measure Information:
Title
Mean change in HbA1c
Description
Mean change in HbA1c from baseline (enrollment) to 12 months after enrollment
Time Frame
Baseline and Day 365
Secondary Outcome Measure Information:
Title
Change in Medications
Description
The change in number and type of medications used to treat type 2 diabetes, hypertension and dyslipidemia from baseline to 12 months
Time Frame
Baseline and Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Catalyst Health Network
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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