Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Prior treatment

• 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)
• 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)

Other illness

• Type 1 Diabetes Mellitus (ICD E10.9)
• 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)
• Cirrhosis, Hepatitis B/C, and Other Chronic Liver Diseases (ICD-10 code: K.74, B19.10, B19.20, K72.1)

Lab values

• Severe renal impairment (eGFR \< 30 mL/min/1.73m²) (ICD N18.4)

Other

• Pregnancy or active breastfeeding (Z33.1, Z39.1)

• 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.