[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05766488":3,"trial-entities:NCT05766488":100,"trial-summary:NCT05766488":105},{"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":24,"interventions":27,"primary_outcomes":43,"secondary_outcomes":48,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":80,"locations":83,"central_contacts":93,"overall_officials":94,"references":98,"see_also_links":99},"NCT05766488","0314-22-FB","Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients","ENROLLING_BY_INVITATION","2026-07","2025-06","2025-09-30","2023-07-24","University of Nebraska","OTHER",false,"Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.","Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population.\n\nEligible adult (\\>=19 years of age) patients at participating clinics with type 2 diabetes, A1c \\>=9%, and concomitant insulin therapy and\u002For using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and\u002For digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.",[18],"Type 2 Diabetes",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28,36],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Continuous Glucose Monitor (CGM)","A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.",[33],"Continuous Glucose Monitoring",[35],"Flash-glucose Monitor",{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"Self-monitoring Blood Glucose (SMBG)","A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.",[40],"Traditional Glucometer Arm",[42],"Traditional glucometer",[44],{"measure":45,"description":46,"timeFrame":47},"Glycemic Control (Hemoglobin A1c)","Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as \\\u003C7.0% vs \\>7.0% to \\\u003C9.0% and \\>9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms.","Baseline, 3 months, and 6 months.",[49,53,56,59],{"measure":50,"description":51,"timeFrame":52},"Hypoglycemia","Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., \\\u003C70 mg\u002FdL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.","6 months",{"measure":54,"description":55,"timeFrame":52},"Hyperglycemia","Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., \\>180 mg\u002Fdl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.",{"measure":57,"description":58,"timeFrame":52},"Blood Glucose Capture Rate","Number of days without any blood glucose recordings will be captured as a percentage over the study period.",{"measure":60,"description":61,"timeFrame":62},"Perceived or Experienced Benefits and Barriers to Device Use","A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey).","Baseline and 6 months","ALL","19 Years",null,true,{"inclusion":68,"exclusion":72,"raw_text":79},[69,70,71],"Type 2 diabetes","A1c \\>9% at recruitment","On\u002Finitiating insulin or on two or more diabetes medications",[73,74,75,76,77,78],"Current use of an insulin pump","On dialysis","Pregnant","Implanted medical device (e.g., pace-maker, defibrillator)","Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM)","Able to read English","Inclusion Criteria:\n\n* Type 2 diabetes\n* A1c \\>9% at recruitment\n* On\u002Finitiating insulin or on two or more diabetes medications\n\nExclusion Criteria:\n\n* Current use of an insulin pump\n* On dialysis\n* Pregnant\n* Implanted medical device (e.g., pace-maker, defibrillator)\n* Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM)\n* Able to read English",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Nebraska Medicine","Omaha","Nebraska","68198-7400D","United States",{"lat":91,"lon":92},41.25626,-95.94043,[],[95],{"name":96,"affiliation":12,"role":97},"Drew C Prescott, PharmD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"Type 2 Diabetes Mellitus",[104],"Hemoglobin A1c measurement",{"nct_id":4,"found":14,"summary":65,"prompt_version":65}]