Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk
Public ClinicalTrials.gov record NCT07032311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effect of Behavioral Intervention/Therapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI/ML Powered Predictive Analytics
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07032311
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2025
- Primary completion
- Dec 30, 2026
- Completion
- Jun 29, 2027
- Last update posted
- Jun 22, 2025
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence | Jamaica | New York | 11432 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07032311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2025 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07032311 live on ClinicalTrials.gov.