Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

Launched by SIPPA SOLUTIONS INC · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a digital program called SIPPA can help adults with type 2 diabetes better manage their blood sugar and reduce the risk of liver problems. The SIPPA program is delivered through an app and includes daily activities to support healthy habits, like tracking blood sugar, diet, and exercise. Researchers want to see if adding this program to usual diabetes care helps lower HbA1c—a blood test that shows average blood sugar levels—more than standard care alone.

People between 22 and 65 years old with type 2 diabetes or prediabetes who can use a smartphone and are willing to make healthy lifestyle changes may be eligible. Participants will have blood tests at the start, 3 months, and 6 months to check blood sugar and liver health. Those in the SIPPA group will also use the app daily and have weekly support calls from a health coach to help stay on track. The study does not include people with certain serious health conditions, such as advanced liver disease, recent heart problems, or untreated depression. This trial is not yet recruiting but aims to find new ways to help people with diabetes improve their health using technology and personalized support.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• 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)
• • 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.