Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

NCT ID
NCT07032311
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
SIPPA Solutions INC

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 180 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria * Age Threshold: Age ≥ 18 years at the time of informed consent. * Clinical Diagnosis: Confirmed diagnosis of Type 2 Diabetes Mellitus (ICD-10: E11.-) supported by: For Type 2 Diabetes: Baseline screening HbA1c above 7.0% (excluding insulin-dependent patients unlikely to benefit from adjunct behavioral intervention). * Medication Stability: Stable pharmacological regimen with no new diabetes medications or dose changes within 90 days of screening. GLP-1 receptor agonists or SGLT-2 inhibitors are permitted only if stable ≥ 90 days prior to screening (status will be captured as a stratification variable). * Clinical Oversight: Currently under the care of a licensed physician or Certified Diabetes Care and Education Specialist (CDCES). * Language \& Literacy: English language proficiency with at least a middle-school reading level, sufficient to independently engage with the SIPPA Health application content. * Device Ownership \& Connectivity: Owns a compatible Android smartphone (or willingness to accept an Android smartphone on a loan basis during the study period) with an active data plan and/or the ability to reliably send and receive text messages. Note: the current validated platform is Android; iOS subjects are not eligible in this study version. * Digital Literacy: Possess the basic technical skills required to operate an Android smartphone and navigate Android mobile applications to receive behavioral intervention/therapy in addition to standard care. * Behavioral Commitment: Expressed willingness to modify behavior, physical activity, and diet, alongside a commitment to communicate with the project team via phone, email, or SMS at least once a week. * Informed Consent: Capable of providing written informed consent. Exclusion Criteria * Current insulin therapy, excluding stable basal insulin (stable ≥ 90 days prior to screening), (ICD Z79.4) * GLP-1 receptor agonist or SGLT-2 inhibitor initiated or dosage change within 90 days of screening (ICD Z79.899) * Type 1 Diabetes Mellitus (ICD E10.9) * Severe renal impairment (eGFR \< 30 mL/min/1.73m²) (ICD N18.4) * Active malignancy or life expectancy \< 12 months (ICD C00 to C96, C51.5) * Active major depressive episode, psychosis, or inpatient psychiatric care within 12 months (ICD F32.A, F32.9, F29, Z65.8) * Pregnancy or active breastfeeding (Z33.1, Z39.1) * Concurrent enrollment in another interventional digital health or behavioral modification study (ICD Z00.6) * Prior use of BT-001 (Better Therapeutics) or SIPPA Health within 6 months of screening * Receiving Hepatotoxic Medication (ICD-10 code: K76.1) * Cirrhosis, Hepatitis B/C, and Other Chronic Liver Diseases (ICD-10 code: K.74, B19.10, B19.20, K72.1)

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence — Jamaica, New York, 11432, United States — Site recruitment status not specified in the registry data

Study details

Start date
August 20, 2026
Primary completion date
October 30, 2027
First posted
June 23, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07032311
Registry last updated
September 14, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07032311 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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