[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568604":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":75,"collaborators":29,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":29,"enrollmentInfo":87,"targetDuration":29,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Institut de Recherches Cliniques de Montreal","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"16g CHO at \u003C 4.0 mmol\u002FL (Reactive Approach)","PLACEBO_COMPARATOR","Participants receive 16 grams of carbohydrate only when their CGM reading falls below 4.0 mmol\u002FL, in line with the traditional \"reactive\" approach. This arm serves as a control, reflecting current hypoglycemia treatment guidelines, allowing comparison to proactive interventions.",[13],"Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"8g CHO at 5.0 mmol\u002FL (Proactive Approach)","EXPERIMENTAL","Participants receive 8 grams of carbohydrate when their CGM reading reaches a proactive threshold of 5.0 mmol\u002FL. This arm tests whether a lower amount of CHO, administered at a higher glucose level, can effectively prevent hypoglycemia with minimal caloric intake.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"16g CHO at 5.0 mmol\u002FL (Proactive Approach)","Participants receive 16 grams of carbohydrate at the proactive threshold of 5.0 mmol\u002FL. This arm examines if a slightly higher dose of CHO at the same proactive threshold provides additional preventive benefits compared to 8 grams, while still aiming to avoid hypoglycemia and limit subsequent glucose fluctuations.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment","The intervention in the REMODAL trial involves administering specific amounts of oral carbohydrates (CHO) at different glucose thresholds to evaluate the effectiveness of proactive versus reactive hypoglycemia management strategies in adults with Type 1 diabetes using continuous glucose monitoring (CGM). Participants will undergo three distinct interventions, each designed to test a different amount and timing of CHO intake.",[20,9,15],null,[31],{"name":32,"affiliation":33,"role":34},"Remi Rabasa-Lhoret","IRCM","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"Valérie Boudreau, PhD","CONTACT","514-987-5643","valerie.boudreau@ircm.qc.ca",{"name":42,"role":38,"phone":43,"phoneExt":29,"email":44},"Corinne Suppere","514-987-5597","corinne.suppere@ircm.qc.ca",[46,65],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Institut de recherches cliniques de Montréal","RECRUITING","Montreal","Quebec","H2W 1R7","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-73.58781,45.50884,{"lat":58,"lon":57},[61,63],{"name":62,"role":38,"phone":29,"phoneExt":29,"email":29},"Corinne Suppère",{"name":64,"role":34,"phone":29,"phoneExt":29,"email":29},"Rémi Rabasa-Lhoret",{"facility":66,"status":48,"city":49,"state":50,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Montreal Clinical Research Institute","H2W1R7",{"type":55,"coordinates":69},[57,58],{"lat":58,"lon":57},[72],{"name":64,"role":38,"phone":73,"phoneExt":29,"email":74},"1-514-987-5762","remi.rabasa-lhoret@ircm.qc.ca",{"type":34,"investigatorFullName":64,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Vice President clinic and clinical research, Professor","100568604","updating-preventive-and-treatment-guidelines-for-hypoglycemia-in-individuals-living-with-type-1-diabetes-100568604",false,"NCT06683391","Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes","Updating pReventive and Treatment guidelinEs for Mild hypOglycemia in Individuals Living With Type 1 Diabetes During the erA of Continuous gLucose Monitoring: The REMODAL Trial","REMODAL","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Clinical diagnosis of Type 1 diabetes for at least 1 year\n* Currently treated with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII), or automated insulin delivery (AID) systems\n* HbA1c level below 9.0%\n* Equal distribution of male and female participants, as well as MDI\u002FCSII and AID users\n\nExclusion Criteria:\n\n* Gastroparesis\n* Significant cardiac rhythm abnormalities\n* Clinically significant microvascular complications such as nephropathy (eGFR \\\u003C 40 ml\u002Fmin) or severe proliferative retinopathy\n* Diagnosis of epilepsy\n* Pregnancy or currently breastfeeding\n* Severe hypoglycemic episode within 1 month prior to inclusion\n* Macrovascular events or uncorrected hypokalemia (K+ \\\u003C 3.5 mmol\u002FL) within 3 months prior to inclusion\n* Anticipated treatment changes during the trial period\n* Inability to provide informed consent","ALL","18 Years",{"count":88,"type":89},32,"ESTIMATED","INTERVENTIONAL",[92],"NA","The REMODAL trial is a randomized crossover study aiming to update treatment guidelines for mild hypoglycemia in people with Type 1 diabetes using continuous glucose monitoring (CGM) technology. The study will assess whether treating mild hypoglycemia proactively (at a glucose threshold of 5.0 mmol\u002FL) with lower doses of carbohydrate (CHO) is more effective than the traditional reactive approach (treatment at \\\u003C 4.0 mmol\u002FL). The goal is to reduce hypoglycemia frequency and improve quality of life, while minimizing caloric intake and rebound hyperglycemia.",[95],"Type 1 Diabetes",[97,98],"type 1 diabetes","hypoglycemia","2025-02-24",{"date":101,"type":102},"2025-02-25","ACTUAL",{"date":104,"type":102},"2025-02-06",{"date":106,"type":89},"2027-12-31",{"name":5,"class":6},2]