Multivariable artificial pancreas for managing diabetes during stress and activity
Multivariable Artificial Pancreas to Detect and Mitigate the Effects of Unannounced Physical Activities and Acute Psychological Stress
This study is testing a new smart insulin delivery system for people with type 1 diabetes to see if it can automatically adjust insulin levels during stress and physical activity without needing constant input from users.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05145374 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a multivariable artificial pancreas (mvAP) that automatically regulates insulin delivery in response to unplanned physical activity and acute psychological stress in individuals with type 1 diabetes. By integrating data from continuous glucose monitoring, the mvAP will address the challenges of maintaining stable blood glucose levels without requiring manual inputs from users. The study will involve 20 participants aged 18-60 who use insulin pumps, focusing on how different types and intensities of physical activity and stress affect insulin sensitivity and metabolism. The goal is to create a user-friendly technology that minimizes the burden on individuals managing diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with type 1 diabetes who are currently using insulin pumps.
Not a fit: Patients with recent metabolic instability or severe diabetes-related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve blood glucose control for patients with type 1 diabetes, reducing the risk of complications associated with the condition.
How similar studies have performed: While there have been advancements in artificial pancreas technology, this specific approach integrating unannounced physical activity and psychological stress is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Men and Women with T1DM Insulin pump users Exclusion Criteria: * Metabolic instability as evidenced by hospitalizations for diabetes or other diabetes-related complications (e.g., diabetic ketoacidosis and hypoglycemic seizures) within the preceding three months; * Severe macrovascular disease, as evidenced by severe peripheral artery disease; history of myocardial infarction, heart failure, thromboembolic disease, or unstable angina; uncontrolled hypertension; abnormal resting EKG; * Maximal exercise stress test with significant brady/tachy arrhythmia, ectopic beats, bundle branch block, or signs of acute ischemia; * Severe microvascular disease as evidenced by history of vision-threatening proliferative or non-proliferative retinal disease; kidney disease; * Any uncontrolled non-musculoskeletal condition that would limit the subject's ability to participate in the exercise program (e.g., chronic obstructive airways disease); * Musculoskeletal conditions such as neurological or orthopedic conditions affecting lower limb strength and mobility (e.g., stroke; insensitive foot); * Pregnancy; * Documented medical condition or physical impairment that is judged by the health care practitioner to contraindicate exercise.
Where this trial is running
Chicago, Illinois
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Ali Cinar — Illinois Institute of Technology
- Study coordinator: Laurie Quinn, PhD
- Email: lquinn1@uic.edu
- Phone: 3127716497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.