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Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

NCT07032311 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-23

No results posted yet for this 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:

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.

Conditions

Interventions

DEVICE

Behavioral Treatment

Description: ARM-2-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy. ARM-2-G2: Patient subjects receiving standard care services that includes GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy.

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    collaborator OTHER

  • SIPPA Solutions INC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032311 on ClinicalTrials.gov