Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSIPPA Solutions INC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Treatment
DeviceA 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: ARM 1: Control Arm (Control - Standard of Care Alone)No intervention 0 interventions
Group B: AMR I: Intervention Arm (Intervention - SIPPA Health + Standard of Care)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to 6 months after randomizationSecondary outcomes
1
Change from Baseline in Body Weight
Evaluates the impact of adjunctive SIPPA Health therapy compared to SOC alone on total body weight change (measured in kilograms).
Time frame
Baseline to Week 242
Proportion of Participants Achieving Glycemic Target (HbA1c < 7.0%)
Percentage of participants in each study arm who achieve a target HbA1c level of less than 7.0% at the completion of Period 1.
Time frame
Week 243
Change from Baseline in Self-Efficacy Survey Score
Measures changes in participant self-management confidence using a Self-Efficacy scale (higher scores indicate greater self-efficacy and confidence in diabetes management).
Time frame
Baseline to Week 24Other outcomes
1
Change from Baseline in Fibrosis-4 (FIB-4) Index Score
Pre-specified exploratory assessment evaluating non-invasive liver fibrosis risk. The FIB-4 index score is calculated using age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count.
Time frame
Baseline to Week 242
Change from Baseline in Continuous Glucose Monitoring (CGM) Glucose Time-in-Range (TIR)
Evaluates changes in the percentage of time spent within the target glycemic range (70-180 mg/dL) among the subset of participants with continuous glucose monitoring (CGM) data available.
Time frame
Baseline to Week 243
Within-Person HbA1c Trajectory During the Open-Label Extension (OLE)
Evaluates individual longitudinal HbA1c changes from Week 24 through Week 52 across participants in both arms, including Control Arm participants who roll over to receive active adjunctive SIPPA Health therapy during Period 2.
Time frame
Week 24 to Week 524
Application Engagement and User Retention Metrics
Tracks digital therapeutic interaction metrics including software engagement frequency, behavioral module completion rates, daily tracking logs, and participant retention during Period 1 (Arm I) and Period 2 OLE (both arms).
Time frame
Baseline through Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SIPPA Solutions INC
Lead sponsor
New York City Health and Hospitals Corporation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: