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Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk
Condition(s) studied
Type 2 DiabetesLiver Disease
Investigational drug(s) / intervention(s)
Behavioral Treatment
Behavioral Treatment: A software-based digital therapeutic mobile application that delivers personalized behavioral therapy, customized diabetes self-management education, and interactive health-tracking tools for individuals with type 2 diabetes or prediabetes.
The intervention includes daily interactive behavioral modules, blood glucose tracking, dietary and physical activity logging, and protocol-guided, non-clinical weekly check-ins with a health navigator to support engagement and reinforcement of the participant's diabetes care plan.
Study summary
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.
Eligibility
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)
Primary outcome measure(s)
- Change in Glycated Hemoglobin (HbA1c) — Baseline to 6 months after randomization
Hemoglobin A1c is reported as a percentage (%) of glycosylated hemoglobin, with typical values ranging from approximately 4% (normal) up to \>14% (poor control). Higher percentages indicate worse long-term glycemic control. Our primary outcome metric is the absolute difference in percentage points (e.g., a decrease from 8.1% at baseline to 7.2% at six months reflects a change of -0.9 percentage points).
Evaluates the clinical efficacy of SIPPA Health used adjunctively with Standard of Care (SOC) compared to SOC alone on glycemic control. HbA1c is measured via standardized blood laboratory assay at baseline and Week 24. A negative change indicates an improvement in blood sugar control.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence |
Jamaica |
New York |
|