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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 25 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Oct 2026, 5 months after the start.
Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's planned 5 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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Clinical Nutrition Research Center, Illinois Institute of Technology →