Effect of Behavioral Intervention/Therapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI/ML Powered Predictive Analytics
SIPPA Solutions INC
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.
Description
Study Purpose and Objectives This study is designed to evaluate whether a smartphone-based behavioral intervention, called SIPPA Health, can enhance the effects of standard diabetes care-including for patients who are prescribed GLP-1 receptor agonists (a common injectable diabetes medication). SIPPA Health, guided by behavioral predictive analytics, delivers daily lifestyle coaching through an app, including exercise goals, meal logging, glucose tracking, and weekly remote check-ins with a trained health navigator. The study will examine whether adding SIPPA to standard treatment improves bl…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Age 22 to 65 * Diagnosed with diabetes and prediabetes with two or more blood work results since 2021 revealing alanine aminotransferase (ALT), aspartate aminotransfe…
Interventions
- DeviceBehavioral 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.
Location
- NYC Health + Hospitals/Queens Hospital Center Diabetes Center of ExcellenceJamaica, New York