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: 200
• 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: Arm 1: Control Group Subgroup 1.1: Participants receiving standard care without GLP-1 medication. Subgroup 1.2: Participants receiving standard care with GLP-1 medication. Arm 2: Intervention Group Subgroup 2.1: Participants receiving standard care without GLP-1 medication, plus the SIPPA behavioral program. Subgroup 2.2: Participants receiving standard care with GLP-1 medication, plus the SIPPA behavioral program. Researchers will compare outcomes across the matched groups in each arm to evaluate the impact of the SIPPA program. What Participants Will Do: All participants will have lab tests at the start of the study, at 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 2) 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; Prediabetes; Liver Disease

Keywords

Type 2 diabetes mellitus; Prediabetes; 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 Hemoglobin A1c (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).

  Baseline to 6 months after randomization

Study Arms (2)

ARM 1: Control without behavioral treatment

NO INTERVENTION

ARM-1-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen. ARM-1-G2: Patient subjects receiving standard care services with GLP-1 medication as part of the treatment regimen.

AMR-2: Behavioral intervention

EXPERIMENTAL

ARM-2-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy. ARM-2-G2: Patient subjects receiving standard care services that includes GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy.

Device: Behavioral Treatment

Interventions

Behavioral Treatment DEVICE

Description: ARM-2-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy. ARM-2-G2: Patient subjects receiving standard care services that includes GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention/therapy.

AMR-2: Behavioral intervention

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Proficiency with a Middle-school Reading Level
• Owning a smartphone or obtaining one on-loan basis during the study period, with a data plan and/or the ability to receive text messages
• Possess basic skills to operate an (Android) smartphone, if you want to receive behavior intervention/therapy in addition to the standard care service
• Willingness to Modify Behavior, Physical activity, and diet
• Age 22 to 65
• Diagnosed with diabetes and prediabetes with two or more blood work results since 2021 revealing alanine aminotransferase (ALT), aspartate aminotransferase (AST), and platelet count (ICD-10 code; Prediabetes: R73.03, Diabetes: E08-E13); whereas prediabetes is clinically defined as two consecutive measure of A1C between 5.8 and 6.5
• Willing to communicate with the project team via phone, email, or SMS once a week

You may not qualify if:

• Consume more than one and a half times the limit of alcohol recommended for the population (15g/day for women and 30 g/day for men) (ICD-10 code: K70.9)
• Pregnancy (ICD-10 code: Z33.3)
• 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)
• Cardiovascular Events in the Past 6 Months and Symptomatic Heart Failure (ICD-10 code: I.21, I.25, I.50, I63.9)
• Stage 4 and Above Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD)(ICD-10 code: N18.4, N18.5, N18.6)
• Untreated Hypothyroidism (ICD-10 code: E03.9)
• Depression (ICD-10 code: F32.A)
• A patient who already received a digital behavioral intervention/therapy prescribed by a clinician is ineligible for this study for safety considerations.

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; Prediabetic State; 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: Participants are randomized into four parallel groups in a 1:1:1:1 fashion, stratified by current GLP-1 receptor agonist use. Two groups receive standard diabetes care (with or without GLP-1 therapy), and two groups receive standard care plus the SIPPA Health app intervention (with or without GLP-1 therapy). All participants follow their assigned regimen concurrently over the 6-month study period.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 23, 2025

Record last verified: 2025-06

Locations

US (1)