Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorClinical Nutrition Research Center, Illinois Institute of Technology

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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/dL at the screening visit, indicating anemia

Men and women with blood pressure >160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit

Women who are pregnant or planning to become pregnant during the study

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

25 Participants
are grouped into 1 trial group