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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Behavioral Treatment
DeviceDescription: 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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SIPPA Solutions INC
Lead sponsor
New York City Health and Hospitals Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options: