[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SIPPA Solutions INC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100595427","digital-behavioral-therapy-to-reduce-diabetes-and-liver-disease-risk-100595427",false,"NCT07032311","Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk","Effect of Behavioral Intervention\u002FTherapy to Reduce Diabetes and Liver Disease Risk Through Prescribed Digital Therapeutics Enabled by AI\u002FML Powered Predictive Analytics","SIPPA-QH_HHC-2","Inclusion Criteria:\n\n* English Proficiency with a Middle-school Reading Level\n* Owning a smartphone or obtaining one on-loan basis during the study period, with a data plan and\u002For the ability to receive text messages\n* Possess basic skills to operate an (Android) smartphone, if you want to receive behavior intervention\u002Ftherapy in addition to the standard care service\n* Willingness to Modify Behavior, Physical activity, and diet\n* Age 22 to 65\n* 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\n* Willing to communicate with the project team via phone, email, or SMS once a week\n\nExclusion Criteria:\n\nConsume more than one and a half times the limit of alcohol recommended for the population (15g\u002Fday for women and 30 g\u002Fday for men) (ICD-10 code: K70.9)\n\n* Pregnancy (ICD-10 code: Z33.3)\n* Receiving Hepatotoxic Medication (ICD-10 code: K76.1)\n* Cirrhosis, Hepatitis B\u002FC, and Other Chronic Liver Diseases (ICD-10 code: K.74, B19.10, B19.20, K72.1)\n* Cardiovascular Events in the Past 6 Months and Symptomatic Heart Failure (ICD-10 code: I.21, I.25, I.50, I63.9)\n* Stage 4 and Above Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD)(ICD-10 code: N18.4, N18.5, N18.6)\n* Untreated Hypothyroidism (ICD-10 code: E03.9)\n* Depression (ICD-10 code: F32.A)\n* A patient who already received a digital behavioral intervention\u002Ftherapy prescribed by a clinician is ineligible for this study for safety considerations.","ALL","22 Years","65 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nMain Research Question:\n\nCan adding the SIPPA behavioral program to standard diabetes care lower HbA1c (a marker of blood sugar control) more than standard care alone?\n\nStudy Design:\n\nThe study has two groups (called \"arms\") for comparison:\n\nArm 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.\n\nArm 2: Intervention Group Subgroup 2.1: Participants receiving standard care without GLP-1 medication, plus the SIPPA behavioral program.\n\nSubgroup 2.2: Participants receiving standard care with GLP-1 medication, plus the SIPPA behavioral program.\n\nResearchers will compare outcomes across the matched groups in each arm to evaluate the impact of the SIPPA program.\n\nWhat Participants Will Do:\n\nAll participants will have lab tests at the start of the study, at 3 months, and at 6 months. These tests include:\n\n* HbA1c (a measure of average blood sugar levels),\n* Fib-4 score (used to estimate liver fibrosis risk), and\n* Liver enzyme tests.\n\nParticipants in the intervention group (Arm 2) will also:\n\n* Use the SIPPA app daily to complete behavioral modules, track blood sugar\n* levels, and log health behaviors (like diet and activity).\n* Have weekly check-ins with a health navigator to support progress and stay on track with their diabetes treatment plan.",[28,29,30],"Type 2 Diabetes","Prediabetes","Liver Disease",[32,29,33,34,35,36,37,38,39,40,41],"Type 2 diabetes mellitus","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","NOT_YET_RECRUITING","2025-06-19",{"date":45,"type":46},"2025-06-23","ACTUAL",{"date":48,"type":22},"2025-07-01",{"date":50,"type":22},"2027-06-30",{"name":52,"class":53},"SIPPA Solutions INC","INDUSTRY",""]