[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560066":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":54,"armGroups":55,"interventions":64,"overallOfficials":70,"centralContacts":74,"locations":79,"responsibleParty":96,"collaborators":50,"id":99,"slug":50,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":50,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":50,"enrollmentInfo":107,"targetDuration":50,"studyType":110,"phases":50,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":82,"whyStopped":50,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[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)",[14,17,20,23,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":12},"Time in Range","Change in the time in range (70-180 mg\u002FdL) at 12 weeks, %, compared within the intervention cohort",{"measure":18,"description":19,"timeFrame":12},"Mean Sensor Glucose","Change in mean sensor glucose concentration at 12 weeks, mg\u002FdL, compared within the intervention cohort",{"measure":21,"description":22,"timeFrame":12},"Time Below Range","Change in time below range (\\\u003C 54mg\u002FdL and \\\u003C 70 mg\u002FdL) at 12 weeks, %, compared within the intervention cohort",{"measure":24,"description":25,"timeFrame":12},"Time Above Range","Change in time above range (\\> 180 mg\u002FdL and \\> 250 mg\u002FdL) at 12 weeks, %, compared within the intervention cohort",{"measure":27,"description":28,"timeFrame":12},"Glycemic Variability","Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort",{"measure":30,"description":31,"timeFrame":12},"Time in Range Increase 5%","Change in the number of subjects increasing 5% or more in time in range (70-180 mg\u002FdL) at 12 weeks, compared within the intervention cohort",{"measure":33,"description":34,"timeFrame":12},"Time in Range Increase 10%","Change in the number of subjects increasing 10% or more in time in range (70-180 mg\u002FdL) at 12 weeks, compared within the intervention cohort",{"measure":36,"description":37,"timeFrame":12},">70% Time in Range","Change in the number of subjects achieving \\> 70% time in range (70-180 mg\u002FdL) at 12 weeks, compared within the intervention cohort",{"measure":39,"description":40,"timeFrame":12},"Hemoglobin A1c \u003C7%","Change in the number of subjects achieving hemoglobin A1c \\\u003C 7% at 12 weeks compared between intervention and historical cohort",{"measure":42,"description":43,"timeFrame":12},"Hemoglobin A1c \u003C8%","Change in the number of subjects achieving hemoglobin A1c \\\u003C 8% at 12 weeks compared between intervention and historical cohort",{"measure":45,"description":46,"timeFrame":12},"Summary of Diabetes Self-Care Activities Measure","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":48,"description":49,"timeFrame":12},"Continuous Glucose Monitoring Survey Responses","Change in survey responses at 12 weeks, compared within the intervention group",null,{"allocation":50,"interventionModel":50,"interventionModelDescription":50,"primaryPurpose":50,"observationalModel":52,"timePerspective":53,"maskingInfo":50},"COHORT","PROSPECTIVE","type 2 diabetes with hemoglobin A1c ≥ 8%",[56,61],{"label":57,"type":50,"description":58,"interventionNames":59},"Continuous glucose monitoring cohort (intervention)","Freestyle libre 2 or 3+ sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 (libre 2) or 15 (libre 3+) days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible.",[60],"Device: FreeStyle Libre 2\u002FLibre 3+ Continuous Glucose Monitor",{"label":62,"type":50,"description":63,"interventionNames":50},"Self-monitoring of blood glucose cohort (historical cohort)","A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1\u002F1\u002F2020-7\u002F1\u002F2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame).",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":50},"DEVICE","FreeStyle Libre 2\u002FLibre 3+ Continuous Glucose Monitor","Subjects included in the intervention group (continuous glucose monitoring) will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks.",[57],[71],{"name":72,"affiliation":5,"role":73},"Kevin Cowart, PharmD, MPH","PRINCIPAL_INVESTIGATOR",[75],{"name":72,"role":76,"phone":77,"phoneExt":50,"email":78},"CONTACT","813-974-5562","kcowart2@usf.edu",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"USF Health Department of Family Medicine","RECRUITING","Tampa","Florida","33612","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-82.45843,27.94752,{"lat":92,"lon":91},[95],{"name":72,"role":76,"phone":77,"phoneExt":50,"email":78},{"type":73,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Kevin Cowart","Associate Professor","100560066",false,"NCT06572306","Pharmacist-led Continuous Glucose Monitoring","Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes","Inclusion Criteria:\n\n* type 2 diabetes\n* hemoglobin A1c ≥ 8%\n* compatible smartphone with FreeStyle Libre 2 or Libre 3+ continuous glucose monitoring system\n* current use and access to a glucometer for self-monitoring of blood glucose\n\nExclusion Criteria:\n\n* any continuous glucose monitor use within 6 months prior to study enrollment\n* pregnant and planning to become pregnant during study time frame\n* history of hypoglycemia requiring third party assistance\n* history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment\n* known allergy to medical grade adhesives\n* current use of systemic steroids for any medical condition\n* current use of dialysis","ALL","18 Years",{"count":108,"type":109},40,"ESTIMATED","OBSERVATIONAL","This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are:\n\n1. to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer).\n2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group)\n3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)",[113],"Type 2 Diabetes",[115,116,117,118],"type 2 diabetes","endocrine disorders","continuous glucose monitor","pharmacist","2026-04-17",{"date":121,"type":122},"2026-04-22","ACTUAL",{"date":124,"type":122},"2024-09-01",{"date":126,"type":109},"2026-06-30",{"name":5,"class":6},1]