An observational study in Type 2 Diabetes and Insulin Dependent Diabetes, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Observational
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.
The 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.
Participants 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.
Participants 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.
The 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.
Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus will be recruited from the Illinois Institute of Technology Clinical Nutrition Research Center proprietary database, online advertisements, social media, community outreach, and local flyers. Eligible participants must be willing to undergo continuous glucose monitoring, wearable activity tracking, dietary assessment, overnight fasting, repeated blood collection, and a liquid meal tolerance test.
Exclusion Criteria:
Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus who will undergo a liquid meal tolerance test with frequent blood sampling over 4 hours following consumption of a standardized liquid meal. Participants will also undergo outpatient continuous glucose monitoring and wearable physical activity tracking during free-living conditions to support mathematical modeling of metabolic and physiologic responses.
Change in Plasma Glucose Concentration (mg/dL)
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/dL
Time frame: -10 to 240 minutes relative to meal consumption
Change in Plasma Insulin Concentration (µIU/mL)
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/mL)
Time frame: -10 to 240 minutes relative to meal consumption
Change in Plasma Glucagon Concentration (pg/mL)
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/mL
Time frame: -10 to 240 minutes relative to meal consumption
Change in Plasma C-Peptide Concentration (ng/mL)
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). Unit of Measure: ng/mL
Time frame: -10 to 240 minutes relative to meal consumption
Change in Plasma Triglyceride Concentration (mg/dL)
Plasma triglyceride 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/dL
Time frame: -10 to 240 minutes relative to meal consumption
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. Unit of Measure: mg/dL
Time frame: Approximately 8 days during outpatient monitoring
Average Daily Step Count (steps/day)
Average daily step count, reported in steps per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Time frame: Approximately 8 days during outpatient monitoring.
Average Daily Active Minutes (minutes/day)
Average daily active minutes, reported in minutes per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Time frame: Approximately 8 days during outpatient monitoring.
Average Daily Sleep Duration (hours/night)
Average sleep duration, reported in hours per night, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Time frame: Approximately 8 days during outpatient monitoring.
Average Resting Heart Rate (beats/minute)
Average resting heart rate, reported in beats per minute (bpm), measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Time frame: Approximately 8 days during outpatient monitoring.
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.
Time frame: Approximately 8 days during outpatient monitoring
Plan to share: Undecided
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Clinical Nutrition Research Center, Illinois Institute of Technology