Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Part of paid clinical trials in Jamaica, New York.

Sponsor: SIPPA Solutions INC
Study ID: NCT07032311
Status: Not Yet Recruiting

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Conditions

Liver Disease
Type 2 Diabetes

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Behavioral Treatment — DEVICE
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 Details

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.

Key Dates

First listed: Jun 23, 2025
Start date: Aug 20, 2026
Status verified: Sep 2026
Primary completion: Oct 30, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 180 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

No Intervention: ARM 1: Control Arm (Control - Standard of Care Alone)
Participants assigned to Arm C receive Standard of Care (SOC) diabetes management alone according to routine clinical practice guidelines, with no exposure or access to the SIPPA Health application during the 24-week core trial (Period 1). Participants undergo protocol-specified clinical and laboratory evaluations at baseline, Week 12 (3 months), and Week 24 (6 months). Following completion of the Week 24 primary endpoint evaluation, participants in Arm C are offered an optional rollover into the 24-week Open-Label Extension (Period 2), where they receive active adjunctive SIPPA Health therapy alongside SOC through Week 52.
Experimental: AMR I: Intervention Arm (Intervention - SIPPA Health + Standard of Care)
Participants assigned to Arm I receive software-based, personalized digital behavioral therapy delivered via the SIPPA Health mobile application adjunctively with Standard of Care (SOC) diabetes management. Upon allocation, participants undergo an onboarding session to establish app access. During the 24-week core trial (Period 1), participants utilize the app daily to complete personalized behavioral modules, log self-monitored blood glucose/health habits, and receive weekly non-clinical support from a health navigator. Following the Week 24 primary endpoint assessment, participants continue receiving active adjunctive SIPPA Health therapy through Week 52 in the Open-Label Extension (Period 2) to assess long-term safety, sustained engagement, and within-person HbA1c trajectories.