Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes
NCT ID: NCT05094401
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
76 participants
INTERVENTIONAL
2021-10-04
2023-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Catalyst Health Network
UNKNOWN
Better Therapeutics
INDUSTRY
Responsible Party
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Locations
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Catalyst Health Network
Plano, Texas, United States
Countries
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Other Identifiers
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DM2-07-CAT
Identifier Type: -
Identifier Source: org_study_id
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