Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Condition(s) studied

Investigational drug(s) / intervention(s)

Behavioral Treatment: A software-based digital therapeutic mobile application that delivers personalized behavioral therapy, customized diabetes self-management education, and interactive health-tracking tools for individuals with type 2 diabetes or prediabetes. The intervention includes daily interactive behavioral modules, blood glucose tracking, dietary and physical activity logging, and protocol-guided, non-clinical weekly check-ins with a health navigator to support engagement and reinforcement of the participant's diabetes care plan.

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:

Intervention Arm (Arm I):

Receives personalized behavioral therapy through the SIPPA Health app alongside Standard of Care (SOC). Participants in this arm complete standardized onboarding and technical readiness training at the start.

Control Arm (Arm C):

Receives Standard of Care (SOC) alone.

What Participants Will Do:

All participants will have lab tests at the start of the study, at baseline, 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 I) 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

Primary outcome measure(s)

• Change in Glycated Hemoglobin (HbA1c) — Baseline to 6 months after randomization
  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). Evaluates the clinical efficacy of SIPPA Health used adjunctively with Standard of Care (SOC) compared to SOC alone on glycemic control. HbA1c is measured via standardized blood laboratory assay at baseline and Week 24. A negative change indicates an improvement in blood sugar control.

Trial sites (1)

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