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Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk

NCT:NCT07032311 · NOT_YET_RECRUITING

NCT IDNCT07032311
狀態NOT_YET_RECRUITING
開始日期2026-08-20
完成時間2027-12-31
SponsorSIPPA Solutions INC (INDUSTRY)
First posted
Last updated

簡要摘要

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.

官方來源

在 ClinicalTrials.gov 上查看 →

資料來自 ClinicalTrials.gov API。最新狀態請參閱官方紀錄。

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