Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

NCT07032311 | Not Yet Recruiting FDA Device

• 1 other identifier: SIPPA-QH_HHC-2025-S1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Liver Disease

Keywords

Type 2 diabetes mellitus; Digital therapeutics; Behavioral intervention; Smartphone app; GLP-1 receptor agonist; Fib-4 score; Randomized pilot trial; Metabolic dysfunction-associated steatotic liver disease (MASLD); Health navigator support; SIPPA Health

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (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). 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.

  Baseline to 6 months after randomization

Secondary Outcomes (3)

• Change from Baseline in Body Weight

  Baseline to Week 24

• Proportion of Participants Achieving Glycemic Target (HbA1c < 7.0%)

  Week 24

• Change from Baseline in Self-Efficacy Survey Score

  Baseline to Week 24

Other Outcomes (4)

• Change from Baseline in Fibrosis-4 (FIB-4) Index Score

  Baseline to Week 24

• Change from Baseline in Continuous Glucose Monitoring (CGM) Glucose Time-in-Range (TIR)

  Baseline to Week 24

• Within-Person HbA1c Trajectory During the Open-Label Extension (OLE)

  Week 24 to Week 52

Study Arms (2)

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

NO INTERVENTION

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

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.

Device: Behavioral Treatment

Interventions

Behavioral Treatment DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• SIPPA Solutions INC: lead
• New York City Health and Hospitals Corporation: collaborator

Study Sites (1)

NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence

Jamaica, New York, 11432, United States

Location

Related Publications (1)

• Sy B, Wassil M, Hassan A, Chen J. Personalizing self-management via behavioral predictive analytics with health education for improved self-efficacy. Patterns (N Y). 2022 May 17;3(6):100510. doi: 10.1016/j.patter.2022.100510. eCollection 2022 Jun 10.

  PMID: 35755867 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Liver Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Digestive System Diseases

Central Study Contacts

Issac Sachmechi, MD

CONTACT

844-692-4692; sachmeci@nychhc.org

Avraham Benhaim, MD

CONTACT

347-404-1478; abenhaim@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial; no participants, investigators, outcome assessors, or data analysts are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study utilizes a 2-period, parallel-group randomized controlled design with a subsequent Open-Label Extension (OLE): Phase 1: Standalone Usability Milestone: Prior to pivotal RCT intake, an independent usability pool (N=15) completes a summative Human Factors Validation (HFV) bench test in a simulated environment to enforce a user interface (UI) freeze. Phase 2: Period 1 (24-Week Pivotal Parallel RCT): Following a two-stage screening process, eligible participants with type 2 diabetes or prediabetes are randomized in a 1:1 ratio to either: Period 2 (Weeks 24 to 52 Open-Label Extension): Following completion of the Week 24 primary endpoint assessment, participants in Arm C (Control) are offered an optional crossover to receive active adjunctive SIPPA Health therapy through Week 52. Participants in Arm I continue active therapy through Week 52 to evaluate long-term safety, sustained behavioral engagement, and within-person biomarker trajectories.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 23, 2025
• Study Start: August 20, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

US (1)