Clinical Trial

Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Study acronym: SIPPA-QH_HHC-2
Not Yet Recruiting
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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: 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.
Trial Details
NCT Number NCT07032311
Lead Sponsor SIPPA Solutions INC
Collaborators: New York City Health and Hospitals Corporation
Conditions Type 2 Diabetes, Prediabetes, Liver Disease
Enrollment 200 participants
Start Date 2025-07-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-23