[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633644":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":60,"studyPopulation":64,"armGroups":65,"interventions":74,"overallOfficials":80,"centralContacts":84,"locations":93,"responsibleParty":118,"collaborators":60,"id":121,"slug":60,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":60,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":60,"studyType":133,"phases":60,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":96,"whyStopped":60,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Change in hemoglobin A1c","Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort","Baseline to End of Study (12 weeks)",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,56,59],{"measure":15,"description":16,"timeFrame":17},"Time in Range","Change in the time in range (70-140 mg\u002FdL) at 4 weeks, %, compared within the intervention cohort","Baseline to End of Week 4 (CGM wear period)",{"measure":19,"description":20,"timeFrame":17},"Time in Euglycemic Range","Change in the time in euglycemic range (54-120 mg\u002FdL) at 4 weeks, %, compared within the intervention cohort",{"measure":22,"description":23,"timeFrame":17},"Mean Sensor Glucose","Change in mean sensor glucose concentration at 4 weeks, mg\u002FdL, compared within the intervention cohort",{"measure":25,"description":26,"timeFrame":17},"Time Below Range","Change in time below range (\\\u003C 70 mg\u002FdL) at 4 weeks, %, compared within the intervention cohort",{"measure":28,"description":29,"timeFrame":17},"Time Above Range","Change in time above range (141-250 mg\u002FdL and \\> 250 mg\u002FdL) at 4 weeks, %, compared within the intervention cohort",{"measure":31,"description":32,"timeFrame":17},"Glycemic Variability","Change in glycemic variability (standard deviation, and Coefficient of variance) at 4 weeks, compared within the intervention cohort",{"measure":34,"description":35,"timeFrame":17},"Time in Range Increase 5%","Change in the number of subjects increasing 5% or more in time in range (70-140 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":37,"description":38,"timeFrame":17},"Time in Range Increase 10%","Change in the number of subjects increasing 10% or more in time in range (70-140 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":40,"description":41,"timeFrame":17},"Time in Euglycemic Range Increase 5%","Change in the number of subjects increasing 5% or more in time in euglycemic range (54-120 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":43,"description":44,"timeFrame":17},"Time in Euglycemic Range Increase 10%","Change in the number of subjects increasing 10% or more in time in euglycemic range (54-120 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":46,"description":47,"timeFrame":17},">70% Time in Range","Change in the number of subjects achieving \\> 70% time in range (70-140 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":49,"description":50,"timeFrame":17},">70% Time in Euglycemic Range","Change in the number of subjects achieving \\> 70% time in euglycemic range (54-120 mg\u002FdL) at 4 weeks, compared within the intervention cohort",{"measure":52,"description":53,"timeFrame":12},"Summary of Diabetes Self-Care Activities Measure (SDSCA)","Change in the Summary of Diabetes Self-Care Activities Measure at 12 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.",{"measure":52,"description":55,"timeFrame":17},"Change in the Summary of Diabetes Self-Care Activities Measure at 4 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.",{"measure":57,"description":58,"timeFrame":12},"36-Item Short Form Health Survey (SF-36)","Change in the 36-Item Short Form Health Survey (SF-36) Measure at 12 weeks, compared within the intervention group. Produces 8 domain scores and is scored on a 0 to 100 scale. For the standard domain scores, higher scores indicate a more favorable health state. A score of 100 reflects the best health status on that domain, and 0 the worst.",{"measure":57,"description":58,"timeFrame":17},null,{"allocation":60,"interventionModel":60,"interventionModelDescription":60,"primaryPurpose":60,"observationalModel":62,"timePerspective":63,"maskingInfo":60},"COHORT","PROSPECTIVE","adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)",[66,71],{"label":67,"type":60,"description":68,"interventionNames":69},"CGM Cohort (Intervention)","Subjects meeting inclusion criteria will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%) obtained within the six months preceding enrollment. Subjects must have a compatible smartphone with the Dexcom CGM sensor system. Subjects must not have worn a CGM in the last 6 months to be eligible.",[70],"Device: Dexcom Stelo CGM",{"label":72,"type":60,"description":73,"interventionNames":60},"No CGM Cohort (Retrospective Cohort)","A retrospective chart review will be performed on patients seen at the USF Health Department of Family Medicine between 1\u002F1\u002F2025-03\u002F20\u002F2026. Subjects in this group will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%). Subjects in this cohort will have not received CGM.",[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":60},"DEVICE","Dexcom Stelo CGM","Subjects included in the intervention group will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. The CGM sensors are worn on the upper arm and changed every 15 days.",[67],[81],{"name":82,"affiliation":5,"role":83},"Kevin Cowart, PharmD, MPH","PRINCIPAL_INVESTIGATOR",[85,89],{"name":82,"role":86,"phone":87,"phoneExt":60,"email":88},"CONTACT","813-974-5562","kcowart2@usf.edu",{"name":90,"role":86,"phone":91,"phoneExt":60,"email":92},"Raechel White, PharmD","813-974-1124","rtwhite@usf.edu",[94,110],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"USF Health Department of Family Medicine - Morsani Center for Advanced Health Care","RECRUITING","Tampa","Florida","33612","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-82.45843,27.94752,{"lat":106,"lon":105},[109],{"name":82,"role":86,"phone":87,"phoneExt":60,"email":88},{"facility":111,"status":96,"city":97,"state":98,"zip":112,"country":100,"countryCode":101,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"USF Health Department of Family Medicine - University Partnership Center","33613",{"type":103,"coordinates":114},[105,106],{"lat":106,"lon":105},[117],{"name":82,"role":86,"phone":87,"phoneExt":60,"email":88},{"type":83,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Kevin Cowart","Associate Professor","100633644",false,"NCT07529366","Pharmacist-Led Continuous Glucose Monitoring for Prediabetes","Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change","Inclusion Criteria:\n\n* adults 18-70 years of age\n* prediabetes (HbA1c 5.7-6.4%)\n* compatible smartphone with the Dexcom Stelo sensor system\n* have not have worn a CGM in the last 6 months prior to enrollment\n\nExclusion Criteria:\n\n* any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes\n* problematic hypoglycemia in the prior 6 months \\[defined as recurrent (more than one) level 2 hypoglycemic events (glucose \\\u003C54mg\u002FdL ) that persist despite multiple attempts to adjust medication(s) and\u002For modify the diabetes\u002Ftreatment plan or a history of one level 3 hypoglycemic event (glucose \\\u003C54mg\u002FdL) characterized by altered mental and\u002For physical state requiring third-party assistance for treatment of hypoglycemia\\]\n* pregnant, or planning to become pregnant during the study time frame\n* currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition\n* a known allergy to medical grade adhesives,\n* use of any CGM device in the past 6 months\n* history of a diagnosed eating disorder\n* current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)\n* subjects lacking capacity to provide informed consent","ALL","18 Years","70 Years",{"count":131,"type":132},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are:\n\n1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group.\n2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.",[136],"Prediabetes",[138,139,140,141,142,143,144,145],"prediabetes","continuous glucose monitoring","pharmacist","health behavior","Hemoglobin A1c","endocrinology","primary care","CGM","2026-05-05",{"date":148,"type":149},"2026-05-11","ACTUAL",{"date":151,"type":132},"2026-06-01",{"date":153,"type":132},"2027-07-31",{"name":5,"class":6},2]