Digital Behavioral Therapy for Type 2 Diabetes and Liver Disease

(SIPPA-QH_HHC-2 Trial)

Overseen By Avraham Benhaim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SIPPA Solutions INC

Must not be taking: Hepatotoxic medications

Disqualifiers: Pregnancy, Chronic liver disease, Cardiovascular events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the SIPPA digital behavioral app can help people with type 2 diabetes manage blood sugar levels more effectively and reduce the risk of liver disease. Participants will be divided into groups: some will use the SIPPA app alongside their regular diabetes care, while others will continue with standard care. Ideal candidates are adults diagnosed with type 2 diabetes who are comfortable using a smartphone and open to adjusting lifestyle habits like diet and exercise. As an unphased trial, this study offers an opportunity to contribute to innovative diabetes care research and potentially improve personal health management.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on standard diabetes care, with or without GLP-1 medication, so you may be able to continue your current treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital programs like the SIPPA app are generally safe for people with type 2 diabetes. These tools help users manage their health by tracking important habits like eating and exercise. While these apps support health management, they typically don't cause physical side effects.

In this trial, participants will use the SIPPA app for daily tasks and have weekly check-ins with a health guide. This approach focuses on changing habits and managing health, which is considered safe. Studies on similar apps have not shown any harmful effects, so the SIPPA program is expected to be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIPPA behavioral program because it offers a novel approach to managing Type 2 Diabetes and Liver Disease by focusing on digital behavioral therapy rather than traditional medication alone. Unlike standard treatments that primarily rely on medications like metformin or insulin to control blood sugar, this program integrates personalized digital therapy to help patients manage their lifestyle and habits, which are key factors in these conditions. This innovative approach could enhance patient engagement and adherence, potentially leading to better long-term health outcomes without additional medication burdens.

What evidence suggests that the SIPPA behavioral program could be effective for type 2 diabetes and liver disease?

Research shows that digital programs like the SIPPA app, which participants in this trial may use, can help people with type 2 diabetes manage their blood sugar levels more effectively. Early results suggest that these apps can enhance diabetes self-care. For instance, some studies have found that personalized programs can lower HbA1c levels, an important measure of blood sugar control. These programs often assist users in tracking their health habits and provide support, leading to better health outcomes. While specific data on the SIPPA program's effect on HbA1c is not yet available, similar digital tools have successfully managed diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with type 2 diabetes and low to moderate risk of liver disease can join this trial. They should be currently receiving standard diabetes care, which may or may not include GLP-1 medication. People who are unable to use a digital app or follow the study protocol will not qualify.

Inclusion Criteria

English Proficiency with a Middle-school Reading Level

Possess basic skills to operate an (Android) smartphone, if you want to receive behavior intervention/therapy in addition to the standard care service

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

Exclusion Criteria

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)

I have been diagnosed with depression.

Pregnancy (ICD-10 code: Z33.3)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard diabetes care, with the intervention group using the SIPPA app for daily behavioral modules and weekly check-ins

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SIPPA behavioral program

Trial Overview The trial is testing if using the SIPPA digital therapeutics app along with standard diabetes care can better control blood sugar and reduce liver fibrosis risk compared to standard care alone. Participants are divided into groups based on their current treatment, with some using the app.

How Is the Trial Designed?

Group I: AMR-2: Behavioral intervention Experimental Treatment 1 Intervention

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.

Group II: ARM 1: Control without behavioral treatment Active Control 1 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.

Who Is Running the Clinical Trial?

SIPPA Solutions INC

Lead Sponsor

New York City Health and Hospitals Corporation

Collaborator

Trials

33

Recruited

8,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032311

Digital Behavioral Therapy to Reduce Diabetes and Liver ... This clinical trial aims to find out if a digital behavioral program, delivered through the SIPPA digital therapeutics app, can help improve blood sugar ...

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-6-2025-63dba

Digital Behavioral Therapy for Type 2 Diabetes and Liver ... This clinical trial aims to find out if a digital behavioral program, delivered through the SIPPA digital therapeutics app, can help improve blood sugar ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666389922001027

Personalizing self-management via behavioral predictive ... The objective of this research is to investigate the feasibility of applying behavioral predictive analytics to optimize diabetes self-management.

4. cell.com cell.com/patterns/pdf/S2666-3899(22)00102-7.pdf

Personalizing self-management via behavioral predictive ... This paper reports the preliminary result of personalizing self-management for 22 subjects under different scenarios and the outcome on ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26414227/

Behavioral Programs for Type 2 Diabetes Mellitus Purpose: To identify factors moderating the effectiveness of behavioral programs for adults with type 2 diabetes. Data sources: 6 databases ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9034646/

Behavioral Predictive Analytics Towards Personalization ... This paper reports the result of manifold clusters based on 148 subjects with type 2 diabetes and shows the preliminary result of ...

7. cell.com cell.com/patterns/fulltext/S2666-3899(22)00102-7

Personalizing self-management via behavioral predictive ... The objective of this research is to investigate the feasibility of applying behavioral predictive analytics to optimize diabetes self-management.

8. file.lacounty.gov file.lacounty.gov/SDSInter/bos/bc/1184967_CAS17042FinalDocument.pdf

Request adoption of the Department of Mental ... - Lacounty outcome data to help inform treatment and track clinic and Countywide program outcomes. The goals of the Statewide Early Psychosis ...