[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06668935":3,"trial-entities:NCT06668935":93,"trial-summary:NCT06668935":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":41,"std_ages":45,"locations":48,"central_contacts":81,"overall_officials":90,"references":91,"see_also_links":92},"NCT06668935","ADC-US-RES-24254","Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring","RECRUITING","2027-01","2024-10","2025-01-15","2024-10-24","Abbott Diabetes Care","INDUSTRY",false,"This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1\u002FGIP) agonists.","Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1\u002FGIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.",[18],"Diabetes Mellitus",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},800,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP\u002FGLP-1 agonists","All subjects will then begin use of their prescribed GLP-1 or combination GIP\u002FGLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.",[32],"Randomization to FSL 3 or Standard of Care",[34],{"measure":35,"description":36,"timeFrame":37},"To assess the length of time subjects in each group remain on a GLP-1 or GLP-1\u002FGIP combination drug","The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide\u002Fglucagon-like peptide 1 (GIP\u002FGLP-1) agonists.","210 days",[],"ALL","18 Years",{"inclusion":42,"exclusion":43,"raw_text":44},[],[],"Inclusion Criteria:\n\n1. Subject must be at least 18 years of age.\n2. Subject must be able to read and understand English.\n3. Subject must have a type 2 diabetes diagnosis.\n4. In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP\u002FGLP-1 medications for management of their diabetes.\n5. Subject is beginning use of GLP-1 \u002F GIP\u002FGLP-1 medication for management of their diabetes.\n6. Subject must be willing to allow venous samples to be obtained to test HbA1c.\n7. Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.\n8. In the investigator's opinion, the subject must be able to follow the instructions provided to him\u002Fher by the study site and perform all study tasks as specified by the protocol.\n9. Subject must be available to participate in all study visits.\n10. Subject must be willing and able to provide written signed and dated informed consent.\n\n    Exclusion Criteria:\n11. Subject is a member of the Study Staff.\n12. Subject has a diagnosis of type 1 or gestational diabetes.\n13. Subject is currently using or has previously used GLP-1 or GIP\u002FGLP-1 drugs for any reason.\n14. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.\n15. Subject has known allergy to medical grade adhesive, isopropyl alcohol and\u002For ethyl alcohol used to disinfect skin.\n16. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.\n17. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.\n18. Subject currently is participating in another clinical trial.\n19. Subject is unsuitable for participation due to any other cause as determined by the Investigator",[46,47],"ADULT","OLDER_ADULT",[49,67],{"facility":50,"status":7,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":64},"East Coast Institute for Research, LLC","Jacksonville","Florida","32216","United States",[56,61],{"name":57,"role":58,"phone":59,"email":60},"Rebecca Goldfaden, Pharm D","CONTACT","904-854-1354","rg@eastcoastresearch.net",{"name":62,"role":63},"Wasim Deeb, MD","PRINCIPAL_INVESTIGATOR",{"lat":65,"lon":66},30.33218,-81.65565,{"facility":68,"status":7,"city":69,"state":52,"zip":70,"country":54,"contacts":71,"geoPoint":78},"Excellence Medical and Research","Miami Gardens","33169",[72,76],{"name":73,"role":58,"phone":74,"email":75},"Alexander Martinez, OD","786-320-5229","amartinez@emrclinic.com",{"name":77,"role":63},"Miguel Trujillo, DNP",{"lat":79,"lon":80},25.94204,-80.2456,[82,86],{"name":83,"role":58,"phone":84,"email":85},"Mohamed Mohamed Nada, PhD","5107495416","adc.clinical@abbott.com",{"name":87,"role":58,"phone":88,"email":89},"Shridhara Karinka, PhD","510 7495416","adc.clinical@abbtott.com",[],[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":98,"summary":99,"prompt_version":109},true,{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an observational study with up to 800 participants across the United States. Participants will be randomly assigned to either use the FreeStyle Libre 3 system or their usual diabetes care.","completed","Observational Study: FreeStyle Libre 3 and GLP-1 Adherence","This study is looking at whether using the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) can help people with type 2 diabetes stay on their GLP-1 or GLP-1\u002FGIP combination medications for a longer time. These medications, like GLP-1 and GIP\u002FGLP-1 agonists, are used to manage diabetes. You might be able to join if you are at least 18 years old, have type 2 diabetes, and are about to start taking one of these medications. The study aims to see how long people in each group stay on their medication, measured over 210 days. The current recruitment status is unclear.","Participants will be followed for approximately 210 days to assess how long they remain on their GLP-1 or GLP-1\u002FGIP medication.",100,"You would be on the study for approximately 210 days. You would wear a sensor on your upper arm and use a paired smartphone to collect glucose readings.","Not stated in the trial record.",[],"v2"]