[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07650682":3,"trial-entities:NCT07650682":124,"trial-summary:NCT07650682":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":66,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":94,"locations":97,"central_contacts":116,"overall_officials":119,"references":122,"see_also_links":123},"NCT07650682","IRB-2026-33","Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes","Mathematical Modeling of Type 2 Diabetes Mellitus","RECRUITING","2027-03-20","2026-06","2026-06-16","2026-05-20","Clinical Nutrition Research Center, Illinois Institute of Technology","INDUSTRY",false,"This observational study aims to collect detailed metabolic and physiologic data from adults with insulin-dependent type 2 diabetes mellitus following consumption of a mixed meal tolerance test. Participants will undergo frequent blood sampling over a 4-hour period after consuming a standardized liquid mixed meal to measure glucose, insulin, glucagon, C-peptide, and triglyceride responses. Participants will also use continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions.\n\nThe purpose of this study is to develop mathematical models and digital representations (\"digital twins\") of people with type 2 diabetes mellitus. These models may help researchers better understand metabolic responses to meals, physical activity, and diabetes treatments, and may support future development of personalized diabetes technologies and therapies.","Participants will first complete a screening visit at the Clinical Nutrition Research Center (CNRC) at the Illinois Institute of Technology. Screening procedures include assessment of medical history, dietary habits, physical activity history, body measurements, vital signs, glycated hemoglobin (HbA1c), and evaluation of eligibility criteria. Eligible participants will receive a continuous glucose monitor (CGM) and wearable activity tracker and will complete dietary recall assessments during the outpatient monitoring period.\n\nParticipants will undergo approximately 8 days of outpatient monitoring using continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions. During this period, participants will continue their usual diabetes management and daily activities while recording dietary intake and medication use.\n\nParticipants will then complete an in-clinic Liquid Meal Test (LMT) visit following an overnight fast. During the study-day visit, an indwelling intravenous catheter will be placed for repeated venous blood collection. Blood samples will be collected before and over a 4-hour period after consumption of a standardized liquid meal consisting of vanilla-flavored Ensure®. Plasma measurements will include glucose, insulin, glucagon, C-peptide, and triglycerides. Participants will remain seated and monitored throughout the study visit, and safety assessments will be performed before discharge.\n\nThe information collected from continuous glucose monitoring, wearable activity tracking, dietary assessments, and repeated blood sampling will be used to develop mathematical models capable of simulating physiologic and metabolic responses in individuals with insulin-dependent type 2 diabetes mellitus. These models may contribute to future research focused on personalized diabetes management, optimization of therapeutic strategies, and evaluation of diabetes technologies.",[19,20],"Type 2 Diabetes","Insulin Dependent Diabetes",[22,23,24],"Liquid Meal Test","Digital Twin","Continuous Glucose Monitoring","OBSERVATIONAL",null,[],{"count":29,"type":30},25,"ESTIMATED",[],[33,37,40,43,46,49,53,57,60,63],{"measure":34,"description":35,"timeFrame":36},"Change in Plasma Glucose Concentration (mg\u002FdL)","Plasma glucose concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: mg\u002FdL","-10 to 240 minutes relative to meal consumption",{"measure":38,"description":39,"timeFrame":36},"Change in Plasma Insulin Concentration (µIU\u002FmL)","Plasma insulin concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: (µIU\u002FmL)",{"measure":41,"description":42,"timeFrame":36},"Change in Plasma Glucagon Concentration (pg\u002FmL)","Plasma glucagon concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex). Unit of Measure: pg\u002FmL",{"measure":44,"description":45,"timeFrame":36},"Change in Plasma C-Peptide Concentration (ng\u002FmL)","Plasma C-peptide concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex).\n\nUnit of Measure: ng\u002FmL",{"measure":47,"description":48,"timeFrame":36},"Change in Plasma Triglyceride Concentration (mg\u002FdL)","Plasma triglyceride concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox).\n\nUnit of Measure: mg\u002FdL",{"measure":50,"description":51,"timeFrame":52},"Continuous Glucose Monitoring Metrics During Free-Living Conditions","Interstitial Glucose Concentration during Free-Living Conditions via Continuous Glucose Monitor Description: Interstitial glucose concentration measured continuously during outpatient free-living conditions using the Dexcom G7 continuous glucose monitoring device.\n\nUnit of Measure: mg\u002FdL","Approximately 8 days during outpatient monitoring",{"measure":54,"description":55,"timeFrame":56},"Average Daily Step Count (steps\u002Fday)","Average daily step count, reported in steps per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.","Approximately 8 days during outpatient monitoring.",{"measure":58,"description":59,"timeFrame":56},"Average Daily Active Minutes (minutes\u002Fday)","Average daily active minutes, reported in minutes per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.",{"measure":61,"description":62,"timeFrame":56},"Average Daily Sleep Duration (hours\u002Fnight)","Average sleep duration, reported in hours per night, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.",{"measure":64,"description":65,"timeFrame":56},"Average Resting Heart Rate (beats\u002Fminute)","Average resting heart rate, reported in beats per minute (bpm), measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.",[67],{"measure":68,"description":69,"timeFrame":52},"Dietary Intake Assessment Using ASA24 Dietary Recall","To assess dietary intake and nutritional patterns using self-reported ASA24 dietary recall assessments during the outpatient monitoring period.","ALL","18 Years","65 Years",{"inclusion":74,"exclusion":82,"raw_text":93},[75,76,77,78,79,80,81],"Men or women, 18-65 years of age","Diagnosed with insulin-dependent type 2 diabetes mellitus HbA1c ≥ 6.5% at screening","Current insulin therapy for ≥ 6 months prior to screening","Nonsmokers (past smokers can be allowed if they have abstained for a minimum of 12 months)","Judged to be in good health based on medical history (i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease)","Able to provide informed consent","Able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary, sample collection procedures, and study visit schedule)",[83,84,85,86,87,88,89,90,91,92],"Men and women with known or suspected intolerance, allergies, or hypersensitivity to study foods","Men and women with low hemoglobin (Hgb) levels below 9.5 g\u002FdL at the screening visit, indicating anemia","Men and women with blood pressure \\>160 mmHg (systolic) \u002F 100 mmHg (diastolic) at the screening visit","Women who are pregnant or planning to become pregnant during the study","Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.","Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator","History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional","Donated blood within the last 3 months","Unstable weight: gained or lost weight +\u002F- 5 kg (11 lbs) in previous 2 months","Unusual working hours i.e., working overnight (e.g. 3rd shift)","Inclusion Criteria:\n\n* Men or women, 18-65 years of age\n* Diagnosed with insulin-dependent type 2 diabetes mellitus HbA1c ≥ 6.5% at screening\n* Current insulin therapy for ≥ 6 months prior to screening\n* Nonsmokers (past smokers can be allowed if they have abstained for a minimum of 12 months)\n* Judged to be in good health based on medical history (i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease)\n* Able to provide informed consent\n* Able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary, sample collection procedures, and study visit schedule)\n\nExclusion Criteria:\n\n* Men and women with known or suspected intolerance, allergies, or hypersensitivity to study foods\n* Men and women with low hemoglobin (Hgb) levels below 9.5 g\u002FdL at the screening visit, indicating anemia\n* Men and women with blood pressure \\>160 mmHg (systolic) \u002F 100 mmHg (diastolic) at the screening visit\n* Women who are pregnant or planning to become pregnant during the study\n* Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.\n* Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator\n* History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional\n* Donated blood within the last 3 months\n* Unstable weight: gained or lost weight +\u002F- 5 kg (11 lbs) in previous 2 months\n* Unusual working hours i.e., working overnight (e.g. 3rd shift)",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":113},"Illinois Institute of Technology","Chicago","Illinois","60616","United States",[105,110],{"name":106,"role":107,"phone":108,"email":109},"Chelsea Preiss, MS","CONTACT","312-567-5300","cpreiss@illinoistech.edu",{"name":111,"role":112},"Indika Edirisinghe, PhD","PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},41.85003,-87.65005,[117],{"name":118,"role":107,"phone":108,"email":109},"Chelsea Preiss, Clinical Research Manager, MS",[120],{"name":121,"affiliation":99,"role":112},"Indika Edirisinghe, Ph.D",[],[],{"nct_id":4,"conditions":125,"biomarkers":127},[126],"Type 2 Diabetes Mellitus",[128],"Hemoglobin A1C Measurement",{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an observational study, meaning there are no interventions or treatments being tested. It plans to enroll 25 participants.","completed","Observational Study on Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes","This study is looking for adults aged 18 to 65 who have type 2 diabetes and use insulin. The goal is to understand how your body's blood sugar (glucose) and hormones like insulin and glucagon respond after eating a meal. You'll have blood samples taken frequently over a 4-hour period after a standardized liquid meal. You'll also wear continuous glucose monitors and activity trackers at home for about 8 days. The information collected will help researchers create computer models, or \"digital twins,\" to better understand type 2 diabetes. We're hoping to learn more about how these responses change over time.","Blood sugar and hormone levels will be measured for up to 240 minutes (4 hours) after meal consumption during the in-clinic visit.",100,"You will have a screening visit, followed by about 8 days of wearing a continuous glucose monitor and activity tracker at home. Then, you'll have an in-clinic visit for a liquid meal test, which involves frequent blood draws over 4 hours.","Not stated in the trial record.",[],"v2"]