Use of an Investigational Digital Therapeutic in Patients... | NCT05094401

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

NCT05094401

Sponsor

Better Therapeutics

Status

Terminated

Last Update Posted

Sep 28, 2023Actual

Enrollment

76Actual

Phase

Phase 3

Conditions

Type2 Diabetes

Interventions

BT-001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor/Investigator Decision

Expanded Access Info

Start Date

Oct 4, 2021Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

Apr 1, 2023Actual

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Name	Class
Catalyst Health Network	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Catalyst Health Network		Plano	Texas	75024	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided