Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk (SIPPA-QH_HHC-2)

SIPPA Solutions INC

Status: Not yet enrolling

Conditions: Type 2 Diabetes; Liver Disease

Treatments: Device: Behavioral Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07032311

SIPPA-QH_HHC-2025-S1

Details and patient eligibility

About

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.

Full 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 blood sugar control, reduces liver fibrosis risk, supports weight management, and helps personalize diabetes care through digital tools. Specific objectives include:

Glycemic Control: Measure changes in hemoglobin A1c (HbA1c)-a long-term blood sugar marker between those who use the SIPPA app and those who receive standard care alone.

Liver Health: Measure Fibrosis-4 (Fib-4) index, an estimate of liver scarring, between those who use the SIPPA app and those who receive standard care alone.

Population-level Diabetes Risk Indicator: Assess whether there is a difference in the distributions between SIPPA users and patients receiving only standard care service; where the distribution will consider BMI change, A1c progression, glucose variability (time-in-range), and engagement with self-care activities.

AI Risk Stratification (Pilot): Test a machine learning model that classifies participants by clinical, behavioral, and social determinants of health data. The aim is to inform future personalized care plans.

Study Design

Here are the updated Brief Summary and Detailed Description sections aligned with your complete multi-phase protocol architecture (Phase 1 HFV Usability Gate, 2-Stage Consent, 1:1 RCT, and 24-Week OLE) for ClinicalTrials.gov PRS:

1. Brief Summary Brief Summary

The goal of this study is to evaluate the usability, clinical efficacy, and metabolic impact of a digital behavioral therapy program delivered via the SIPPA Health mobile application in adults with type 2 diabetes or prediabetes. The main question it aims to answer is:

Can adding the SIPPA Health application to standard diabetes care improve blood sugar control (HbA1c) more than standard care alone over 24 weeks?

Study Design

The program is structured in two sequential phases:

Phase 1 (Standalone Usability Milestone):

A summative Human Factors Validation (HFV) study in a simulated environment (N=15) to evaluate user interface safety and enforce a UI freeze before clinical trial enrollment.

Phase 2 (Pivotal 1:1 Randomized Controlled Trial):

A 24-week parallel-group trial (N=180) involving adults with type 2 diabetes. Eligible participants who complete pre-screening are randomly assigned 1:1 to either:

ARM I (Intervention Group): Standard care plus the SIPPA Health app. ARM C (Control Group): Standard care alone.

All participants complete the same laboratory and survey assessments at baseline, 3 months, and 6 months. These include blood tests (A1c, liver enzymes, lipids), weight, and self-reported lifestyle data. SIPPA users also receive a smartphone app with daily reminders, educational content, and weekly coaching calls to support their self-care routines.

Outcome Measures Primary Clinical Outcome (Baseline to Week 24) Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24

Secondary Outcomes Change from Baseline in Body Weight at Week 24. Evaluate the impact of adjunctive SIPPA Health therapy on total body weight change (in kilograms).

Proportion of Participants Achieving Glycemic Control (HbA1c < 7.0%) at Week 24. Assess proportion of subjects who achieve a target HbA1c value of less than 7.0%.

Change from Baseline in Diabetes Self-Efficacy Score at Week 24. Evaluate changes in participant self-efficacy and diabetes management as measured by the Self-Efficacy survey.

Incidence of Adverse Events, Hypoglycemic Episodes, and Usability Incidents. Characterizes the safety and usability profile of SIPPA Health, tracking the frequency and severity of overall adverse events (AEs), severe/symptomatic hypoglycemic events, and software/usability-related incidents from baseline through Week 52 (includes Period 1 and Open-Label Extension).

Exploratory Outcomes Change from Baseline in Fibrosis-4 (FIB-4) Index Score at Week 24. Pre-specified exploratory assessment of non-invasive liver fibrosis risk. The FIB-4 index is calculated using age, AST, ALT, and platelet count.

Change from Baseline in Glucose Time-in-Range (TIR) at Week 24. Evaluate changes in the percentage of time spent within the target glycemic range (70-180 mg/dL) among participants with available Continuous Glucose Monitoring (CGM) data.

Within-Person Trajectory of HbA1c During the Open-Label Extension (OLE). Longitudinal evaluation of individual HbA1c changes from Week 24 to Week 52 among participants in both arms, including Control Arm participants who roll over to receive active SIPPA Health therapy.

Digital Therapeutic App Engagement and User Retention Metrics. Tracks application interaction levels, module completion rates, tracking frequency, and user retention during Period 1 (Intervention Arm) and Period 2 OLE (both arms). For SIPPA users, the study will track the number of logins, modules completed, step counts, and minutes spent in coaching calls.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age Threshold: Age ≥ 18 years at the time of informed consent.
• Clinical Diagnosis: Confirmed diagnosis of Type 2 Diabetes Mellitus (ICD-10: E11.-) supported by: For Type 2 Diabetes: Baseline screening HbA1c above 7.0% (excluding insulin-dependent patients unlikely to benefit from adjunct behavioral intervention).
• Medication Stability: Stable pharmacological regimen with no new diabetes medications or dose changes within 90 days of screening. GLP-1 receptor agonists or SGLT-2 inhibitors are permitted only if stable ≥ 90 days prior to screening (status will be captured as a stratification variable).
• Clinical Oversight: Currently under the care of a licensed physician or Certified Diabetes Care and Education Specialist (CDCES).
• Language & Literacy: English language proficiency with at least a middle-school reading level, sufficient to independently engage with the SIPPA Health application content.
• Device Ownership & Connectivity: Owns a compatible Android smartphone (or willingness to accept an Android smartphone on a loan basis during the study period) with an active data plan and/or the ability to reliably send and receive text messages. Note: the current validated platform is Android; iOS subjects are not eligible in this study version.
• Digital Literacy: Possess the basic technical skills required to operate an Android smartphone and navigate Android mobile applications to receive behavioral intervention/therapy in addition to standard care.
• Behavioral Commitment: Expressed willingness to modify behavior, physical activity, and diet, alongside a commitment to communicate with the project team via phone, email, or SMS at least once a week.
• Informed Consent: Capable of providing written informed consent.

Exclusion Criteria

• Current insulin therapy, excluding stable basal insulin (stable ≥ 90 days prior to screening), (ICD Z79.4)
• GLP-1 receptor agonist or SGLT-2 inhibitor initiated or dosage change within 90 days of screening (ICD Z79.899)
• Type 1 Diabetes Mellitus (ICD E10.9)
• Severe renal impairment (eGFR < 30 mL/min/1.73m²) (ICD N18.4)
• Active malignancy or life expectancy < 12 months (ICD C00 to C96, C51.5)
• Active major depressive episode, psychosis, or inpatient psychiatric care within 12 months (ICD F32.A, F32.9, F29, Z65.8)
• Pregnancy or active breastfeeding (Z33.1, Z39.1)
• Concurrent enrollment in another interventional digital health or behavioral modification study (ICD Z00.6)
• Prior use of BT-001 (Better Therapeutics) or SIPPA Health within 6 months of screening
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

ARM 1: Control Arm (Control - Standard of Care Alone)

No Intervention group

Description:

Participants assigned to Arm C receive Standard of Care (SOC) diabetes management alone according to routine clinical practice guidelines, with no exposure or access to the SIPPA Health application during the 24-week core trial (Period 1). Participants undergo protocol-specified clinical and laboratory evaluations at baseline, Week 12 (3 months), and Week 24 (6 months). Following completion of the Week 24 primary endpoint evaluation, participants in Arm C are offered an optional rollover into the 24-week Open-Label Extension (Period 2), where they receive active adjunctive SIPPA Health therapy alongside SOC through Week 52.

AMR I: Intervention Arm (Intervention - SIPPA Health + Standard of Care)

Experimental group

Description:

Participants assigned to Arm I receive software-based, personalized digital behavioral therapy delivered via the SIPPA Health mobile application adjunctively with Standard of Care (SOC) diabetes management. Upon allocation, participants undergo an onboarding session to establish app access. During the 24-week core trial (Period 1), participants utilize the app daily to complete personalized behavioral modules, log self-monitored blood glucose/health habits, and receive weekly non-clinical support from a health navigator. Following the Week 24 primary endpoint assessment, participants continue receiving active adjunctive SIPPA Health therapy through Week 52 in the Open-Label Extension (Period 2) to assess long-term safety, sustained engagement, and within-person HbA1c trajectories.

Treatment:

Device: Behavioral Treatment