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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioral Treatment

    Device

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ARM 1: Control without behavioral treatmentNo intervention 0 interventions
Group B: AMR-2: Behavioral interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin A1c (HbA1c)

Hemoglobin A1c is reported as a percentage (%) of glycosylated hemoglobin, with typical values ranging from approximately 4% (normal) up to \>14% (poor control). Higher percentages indicate worse long-term glycemic control. Our primary outcome metric is the absolute difference in percentage points (e.g., a decrease from 8.1% at baseline to 7.2% at six months reflects a change of -0.9 percentage points).

Time frame
Baseline to 6 months after randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SIPPA Solutions INC

Lead sponsor

New York City Health and Hospitals Corporation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: