Liver Disease, Type 2 Diabetes
Conditions
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
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.
Detailed 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.
Interventions
DEVICEBehavioral 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.
Sponsors
SIPPA Solutions INC
New York City Health and Hospitals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial; no participants, investigators, outcome assessors, or data analysts are blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Body Weight | Baseline to Week 24 | Evaluates the impact of adjunctive SIPPA Health therapy compared to SOC alone on total body weight change (measured in kilograms). |
| Proportion of Participants Achieving Glycemic Target (HbA1c < 7.0%) | Week 24 | Percentage of participants in each study arm who achieve a target HbA1c level of less than 7.0% at the completion of Period 1. |
| Change from Baseline in Self-Efficacy Survey Score | Baseline to Week 24 | Measures changes in participant self-management confidence using a Self-Efficacy scale (higher scores indicate greater self-efficacy and confidence in diabetes management). |
Countries
United States
Contacts
CONTACTIssac Sachmechi, MD
CONTACTAvraham Benhaim, MD
Outcome results
None listed