[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07639593":3,"trial-entities:NCT07639593":113,"trial-summary:NCT07639593":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":67,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":83,"locations":86,"central_contacts":105,"overall_officials":108,"references":111,"see_also_links":112},"NCT07639593","IRB00143795","Trial of CGM Technology in Persons Living With Prediabetes","Trial of Continuous Glucose Monitoring (CGM) Technology in Persons Living With Prediabetes","NOT_YET_RECRUITING","2027-03","2026-05","2026-06-24","2026-08","Wake Forest University Health Sciences","OTHER",false,"Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes. While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.","Additional investigation is strongly needed to further evaluate the health impacts of CGM technology in persons living with prediabetes. This study is looking to study the impact that CGM technology could have on glycemic control in patients with prediabetes, as well as secondary outcomes, such as blood pressure, weight, and patient insight into their condition and the effect on lifestyle interventions on glycemic control. The primary objective of this study is to determine the effect of CGM technology on glycemic control in patients with prediabetes, measured by the endpoints of A1c and CGM data. Specifically, CGM data will include Time-In-Range (TIR), Time-AboveRange (TAR), Time-Below-Range (TBR), Glycemic management indicator (GMI), and variability measures. Secondary endpoints include blood pressure, weight, and standardized survey data assessing behavioral modifications as a result of CGM technology.",[19],"Prediabetes",[21,22,23],"Continuous Glucose Monitoring","A1C (or HbA1c)","diabetes","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DEVICE","Stelo CGM","The Stelo Glucose Biosensor is built on the most accurate continuous glucose monitoring technology from Dexcom and is simple and painless to apply. By sending glucose levels directly to your smartphone,\\* it gives you just the right amount of information to work with.",[37],"Stelo CGM Device",[39],"Simple Sugar Tracking",[41,45,47,50,52,54,55,58,59,60,61,64,65,66],{"measure":42,"description":43,"timeFrame":44},"A1c value","An A1C test measures your average blood sugar levels over the past 2 to 3 months. It is reported as a percentage. A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal","Baseline",{"measure":42,"description":43,"timeFrame":46},"Month 3",{"measure":48,"description":49,"timeFrame":44},"CGM value","Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24\u002F7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg\u002FdL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows.",{"measure":48,"description":49,"timeFrame":51},"Month 1",{"measure":48,"description":49,"timeFrame":53},"Month 2",{"measure":48,"description":49,"timeFrame":46},{"measure":56,"description":57,"timeFrame":44},"Weight monitoring","Weight measurement will be collected",{"measure":56,"description":57,"timeFrame":51},{"measure":56,"description":57,"timeFrame":53},{"measure":56,"description":57,"timeFrame":46},{"measure":62,"description":63,"timeFrame":44},"Blood Pressure Monitoring","Systolic (Top Number)Diastolic (Bottom Number)\n\nNormal - Less than 120and Less than 80\n\nElevated - 120 - 129 and Less than 80\n\nHypertension Stage 1 - 130 - 139 or 80 - 89\n\nHypertension Stage 2 -140 or higher or 90 or higher\n\nHypertensive Crisis - Higher than 180 and\u002For Higher than 120",{"measure":62,"description":63,"timeFrame":51},{"measure":62,"description":63,"timeFrame":53},{"measure":62,"description":63,"timeFrame":46},[68],{"measure":69,"description":70,"timeFrame":46},"Continuous Glucose Monitoring As a Behavior Modification Tool Survey","The results will be discussed by describing the percent of patients that said \"Yes,\" \"No,\" or \"I don't know\" to the questions - percentage data","ALL","18 Years",null,{"inclusion":75,"exclusion":78,"raw_text":82},[76,77],"Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or \\> than 5.7% and \\\u003C or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application","Greater than or equal to 18 years old",[79,80,81],"Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c \\> or = 6.5%","Subjects who do not have reliable access to a smartphone device compatible with the CGM application","Pregnant patients","Inclusion Criteria:\n\n* Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or \\> than 5.7% and \\\u003C or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application\n* Greater than or equal to 18 years old\n\nExclusion Criteria:\n\n* Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c \\> or = 6.5%\n* Subjects who do not have reliable access to a smartphone device compatible with the CGM application\n* Pregnant patients",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":13,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":102},"Winston-Salem","North Carolina","27157","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Meghan Willoughby, MD","CONTACT","317-938-5421","meghan.willoughby@advocatehealth.org",{"name":99,"role":95,"phone":100,"email":101},"Catherine Price, MD","912-682-0558","Catherine.Price@wfusm.edu",{"lat":103,"lon":104},36.09986,-80.24422,[106,107],{"name":94,"role":95,"phone":96,"email":97},{"name":99,"role":95,"phone":100,"email":101},[109],{"name":99,"affiliation":13,"role":110},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[19],[],{"nct_id":4,"found":15,"summary":73,"prompt_version":73}]