[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595427":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":35,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":88,"whyStopped":12,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"SIPPA Solutions INC","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM 1: Control without behavioral treatment","NO_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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"AMR-2: Behavioral intervention","EXPERIMENTAL","ARM-2-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention\u002Ftherapy. 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\u002Ftherapy.",[18],"Device: Behavioral Treatment",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Behavioral Treatment","Description: ARM-2-G1: Patient subjects receiving standard care services without GLP-1 medication as part of the treatment regimen, and SIPPA Health behavioral intervention\u002Ftherapy. 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\u002Ftherapy.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Issac Sachmechi, MD","CONTACT","844-692-4692","sachmeci@nychhc.org",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Avraham Benhaim, MD","347-404-1478","abenhaim@northwell.edu",[36],{"facility":37,"status":12,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":12},"NYC Health + Hospitals\u002FQueens Hospital Center Diabetes Center of Excellence","Jamaica","New York","11432","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-73.80569,40.69149,{"lat":47,"lon":46},{"type":50,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[52],{"name":53,"class":54},"New York City Health and Hospitals Corporation","OTHER","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":67,"type":68},200,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75,76],"Type 2 Diabetes","Prediabetes","Liver Disease",[78,75,79,80,81,82,83,84,85,86,87],"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":91,"type":92},"2025-06-23","ACTUAL",{"date":94,"type":68},"2025-07-01",{"date":96,"type":68},"2027-06-30",{"name":5,"class":6},1]