[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580423":3},{"organization":4,"outcomesModule":7,"designInfo":86,"detailedDescription":87,"studyPopulation":90,"armGroups":91,"interventions":104,"overallOfficials":87,"centralContacts":87,"locations":110,"responsibleParty":133,"collaborators":135,"id":139,"slug":87,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":87,"enrollmentInfo":148,"targetDuration":151,"studyType":152,"phases":87,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":112,"whyStopped":87,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"LMC Diabetes & Endocrinology Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":79},[9],{"measure":10,"description":11,"timeFrame":12},"Change in HbA1c","Evaluate the change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D","from enrollment to 3-6 month follow up",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,57,60,63,66,69,71,74,76],{"measure":15,"description":16,"timeFrame":12},"Change in Weight","Evaluate the change in weight in the isCGM and CBG cohorts",{"measure":18,"description":19,"timeFrame":12},"Change in BMI","Evaluate the change in body mass index (BMI) in the isCGM and CBG cohorts",{"measure":21,"description":22,"timeFrame":12},"Change in Blood Pressure","Evaluate the change in blood pressure in the isCGM and CBG cohorts",{"measure":24,"description":25,"timeFrame":12},"Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up","Evaluate the proportion of participants achieving HbA1c ≤ 7.0% at follow-up in the isCGM and CBG cohort",{"measure":27,"description":28,"timeFrame":12},"Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week","Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM and CBG cohort",{"measure":30,"description":31,"timeFrame":12},"Percent Time in Range (TIR)","Evaluate percent time in range (3.9 to 10.0 mmol\u002FL) in the isCGM and isCGM+Coaching cohorts",{"measure":33,"description":34,"timeFrame":12},"Percent Time Below Range (TBR)","Evaluate percent time below range (\\\u003C 3.9 mmol\u002FL) in the isCGM and isCGM+Coaching cohorts",{"measure":36,"description":37,"timeFrame":12},"Percent Time Below Range (TBR) in Level 2 Hypoglycemia","Evaluate Percent TBR in level 2 hypoglycemia (\\\u003C 3.0 mmol\u002FL) in the isCGM and isCGM+Coaching cohorts",{"measure":39,"description":40,"timeFrame":12},"Percent Time Above Range (TAR)","Evaluate Percent TAR (\\> 10.0 mmol\u002FL) in the isCGM and isCGM+Coaching cohorts",{"measure":42,"description":43,"timeFrame":12},"Estimated Glucose Management Indicator (eGMI)","Evaluate the Estimated Glucose Management Indicator (eGMI) in the isCGM and isCGM+Coaching cohorts",{"measure":45,"description":46,"timeFrame":12},"Mean glucose","Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts",{"measure":48,"description":49,"timeFrame":12},"Glycemic variability","Evaluate glycemic variability reported as SD and CV in the isCGM and isCGM+Coaching cohorts",{"measure":51,"description":52,"timeFrame":12},"Percent sensor capture","Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts",{"measure":54,"description":55,"timeFrame":56},"Number of isCGM discontinuations","Evaluate the number of isCGM discontinuations in the isCGM and isCGM+Coaching cohorts only at follow-up","assessed at 3-6 month follow-up",{"measure":58,"description":59,"timeFrame":12},"Number of diabetes coaching program discontinuations","Evaluate the number of diabetes coaching program discontinuations, measured by the Diabetes Coaching Program survey in the isCGM and isCGM+Coaching cohorts",{"measure":61,"description":62,"timeFrame":12},"Psychological distress","Evaluate psychological distress measured by the Diabetes Distress Scale (DDS) in the isCGM and isCGM+Coaching cohorts",{"measure":64,"description":65,"timeFrame":12},"Glucose monitoring device satisfaction","Evaluate glucose monitoring device satisfaction measured by the Glucose Monitoring System Satisfaction Scale (GMSS) in the isCGM and isCGM+Coaching cohorts",{"measure":67,"description":68,"timeFrame":56},"Proportion of participants achieving HbA1c ≤ 7.0%","Evaluate proportion of participants achieving HbA1c ≤ 7.0% in the isCGM and isCGM+Coaching cohorts at follow-up only",{"measure":15,"description":70,"timeFrame":12},"Evaluate change in weight in only the isCGM+Coaching cohort",{"measure":72,"description":73,"timeFrame":12},"Change in Body Mass Index (BMI)","Evaluate the change in body mass index in only the isCGM+Coaching cohort",{"measure":21,"description":75,"timeFrame":12},"Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort",{"measure":77,"description":78,"timeFrame":12},"Proportion of participants with ≥1 self-reported hypoglycemic event per week","Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM+Coaching cohort only",[80,83],{"measure":81,"description":82,"timeFrame":56},"Change in HbA1c by Age","Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by age \\\u003C 65 years old vs ≥ 65 years old subgroups",{"measure":84,"description":85,"timeFrame":56},"Change in HbA1c by Baseline HbA1c","Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by baseline HbA1c (\\\u003C 8.5% vs ≥ 8.5% subgroups)",{"allocation":87,"interventionModel":87,"interventionModelDescription":87,"primaryPurpose":87,"observationalModel":88,"timePerspective":89,"maskingInfo":87},null,"COHORT","PROSPECTIVE","The study population will be adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation (isCGM cohort) or complete 2 or more diabetes coaching program consultations (isCGM+coaching cohort), or use a CBG monitor (CBG cohort)",[92,97,100],{"label":93,"type":87,"description":94,"interventionNames":95},"isCGM Group","Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation",[96],"Device: Intermittently Scanned Continuous Glucose Monitor",{"label":98,"type":87,"description":99,"interventionNames":87},"CBG Group","Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor",{"label":101,"type":87,"description":102,"interventionNames":103},"isCGM+Coaching Group","Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete 2 or more diabetes coaching program consultations",[96],[105],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":87},"DEVICE","Intermittently Scanned Continuous Glucose Monitor","intervention used by the isCGM and isCGM+Coaching groups",[93,101],[111],{"facility":5,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"RECRUITING","Toronto","Ontario","M4G 3E8","Canada","CA",{"type":119,"coordinates":120},"Point",[121,122],-79.39864,43.70643,{"lat":122,"lon":121},[125,130],{"name":126,"role":127,"phone":128,"phoneExt":87,"email":129},"Manager, Data Science","CONTACT","4166452929","lisa.chu@lmc.ca",{"name":131,"role":127,"phone":87,"phoneExt":87,"email":132},"Research Assistant, Data Science","giovana.romero@lmc.ca",{"type":134,"investigatorFullName":87,"investigatorTitle":87,"investigatorAffiliation":87,"oldNameTitle":87,"oldOrganization":87},"SPONSOR",[136],{"name":137,"class":138},"Sun Life Assurance Company of Canada","UNKNOWN","100580423",false,"NCT06837103","Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Not Using Insulin (REAL isCGM T2D)","Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents","REAL isCGM T2D","Inclusion Criteria:\n\n* 18 years or older\n* Clinical diagnosis of T2D ≥ one year\n* Using at least one AHA\n* Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)\n* Baseline HbA1c ≥ 7.0%\n* ≥ 1 HbA1c value up to 6 months prior to index date\n* Exclusive use of isCGM for ≥ 3 months\n* Informed consent\n\nExclusion Criteria:\n\n* Have a history of insulin use\n* Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study\n* Have an estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m2\n* Previously used rtCGM or isCGM for \\> 3 months\n* Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date","ALL","18 Years",{"count":149,"type":150},250,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a specialist endocrinology clinical setting in Canada.\n\nPrimary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D.\n\nSecondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and\u002For evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks).\n\nExploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (\\\u003C 65 years old vs ≥ 65 years old) and baseline HbA1c (\\\u003C 8.5% vs ≥ 8.5%).",[155],"Type 2 Diabetes",[157,158,159,160],"continuous glucose monitoring","type 2 diabetes","time in range","HbA1c","2025-04-30",{"date":163,"type":164},"2025-05-04","ACTUAL",{"date":166,"type":164},"2025-04-09",{"date":168,"type":150},"2026-05",{"name":5,"class":6},1]