Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorSIPPA Solutions INC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Behavioral Treatment

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

SIPPA Solutions INC

Lead sponsor

New York City Health and Hospitals Corporation

Collaborator