Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk
Effect of Behavioral Intervention/Therapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI/ML Powered Predictive Analytics
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All participants complete the same laboratory and survey assessments at baseline, 3 months, and 6 months."
- "These include blood tests (A1c, liver enzymes, lipids), weight, and self-reported lifestyle data."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding the SIPPA app to usual diabetes care improves blood sugar more than usual care alone. It also looks at whether the app lowers the risk of liver scarring. It is for adults with type 2 diabetes who have a low to moderate risk of liver disease.
This clinical trial aims to find out if a digital behavioral program, delivered through the SIPPA digital therapeutics app, can help improve blood sugar control and lower the risk of liver fibrosis in adults with type 2 diabetes who are at low to moderate risk for liver disease. Main Research Question: Can adding the SIPPA behavioral program to standard diabetes care lower HbA1c (a marker of blood sugar control) more than standard care alone? Study Design: The study has two groups (called "arms") for comparison: Intervention Arm (Arm I): Receives personalized behavioral therapy through the SIPPA Health app alongside Standard of Care (SOC). Participants in this arm complete standardized onboarding and technical readiness training at the start. Control Arm (Arm C): Receives Standard of Care (SOC) alone. What Participants Will Do: All participants will have lab tests at the start of the study, at baseline, 3 months, and at 6 months. These tests include: * HbA1c (a measure of average blood sugar levels), * Fib-4 score (used to estimate liver fibrosis risk), and * Liver enzyme tests. Participants in the intervention group (Arm I) will also: * Use the SIPPA app daily to complete behavioral modules, track blood sugar * levels, and log health behaviors (like diet and activity). * Have weekly check-ins with a health navigator to support progress and stay on track with their diabetes treatment plan.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and able to give written consent to join.
- Have confirmed type 2 diabetes and an HbA1c above 7.0% at screening. HbA1c measures average blood sugar.
- Have no new diabetes medicines or dose changes in the 90 days before screening.
- Be under the care of a licensed doctor or certified diabetes care and education specialist.
- Read English at least at a middle-school level and be able to use the app on your own.
- Own a compatible Android phone or agree to borrow one during the study. Have an active data plan or reliable text messaging; this study does not support iPhones.
- Have basic skills to use an Android phone and its apps.
- Be willing to change habits, activity, and diet, and contact the study team by phone, email, or text at least weekly.
Who can't join
- Have type 1 diabetes, or use insulin other than long-acting background insulin that has been stable for at least 90 days.
- Started or changed the dose of a GLP-1 or SGLT-2 diabetes medicine within 90 days before screening.
- Have severe kidney problems, with a kidney filtering rate called eGFR below 30.
- Have active cancer or an expected lifespan of less than 12 months.
- Have a current major episode of depression, psychosis (trouble knowing what is real), or a hospital stay for mental health care within 12 months.
- Are pregnant or breastfeeding.
- Are in another study testing a digital health or behavior-change treatment, or used BT-001 (Better Therapeutics) or SIPPA Health within 6 months before screening.
- Take medicine that can harm the liver, or have cirrhosis (severe liver scarring), hepatitis B or C, or another long-term liver disease.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
NY
- NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence · Jamaica, NY 11432More trials in Jamaica