What this trial means for you
This study is opening soon at 1 US site. It's studying see the official record for type 2 diabetes, prediabetes, liver disease.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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: Arm 1: Control Group Subgroup 1.1: Participants receiving standard care without GLP-1 medication. Subgroup 1.2: Participants receiving standard care with GLP-1 medication. Arm 2: Intervention Group Subgroup 2.1: Participants receiving standard care without GLP-1 medication, plus the SIPPA behavioral program. Subgroup 2.2: Participants receiving standard care with GLP-1 medication, plus the SIPPA behavioral program. Researchers will compare outcomes across the matched groups in each arm to evaluate the impact of the SIPPA program. What Participants Will Do: All participants will have lab tests at the start of the study, at 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 2) 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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * English Proficiency with a Middle-school Reading Level * Owning a smartphone or obtaining one on-loan basis during the study period, with a data plan and/or the ability to receive text messages * Possess basic skills to operate an (Android) smartphone, if you want to receive behavior intervention/therapy in addition to the standard care service * Willingness to Modify Behavior, Physical activity, and diet * Age 22 to 65 * Diagnosed with diabetes and prediabetes with two or more blood work results since 2021 revealing alanine aminotransferase (ALT), aspartate aminotransferase (AST), and platelet count (ICD-10 code; Prediabetes: R73.03, Diabetes: E08-E13); whereas prediabetes is clinically defined as two consecutive measure of A1C between 5.8 and 6.5 * Willing to communicate with the project team via phone, email, or SMS once a week Exclusion Criteria: Consume more than one and a half times the limit of alcohol recommended for the population (15g/day for women and 30 g/day for men) (ICD-10 code: K70.9) * Pregnancy (ICD-10 code: Z33.3) * 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) * Cardiovascular Events in the Past 6 Months and Symptomatic Heart Failure (ICD-10 code: I.21, I.25, I.50, I63.9) * Stage 4 and Above Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD)(ICD-10 code: N18.4, N18.5, N18.6) * Untreated Hypothyroidism (ICD-10 code: E03.9) * Depression (ICD-10 code: F32.A) * A patient who already received a digital behavioral intervention/therapy prescribed by a clinician is ineligible for this study for safety considerations.
Study sites by state
New York
- NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence — Jamaica
View the official record on ClinicalTrials.gov →
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