Observational Study: Multivariable Artificial Pancreas for Type 1 Diabetes

This observational study is looking at how a new type of artificial pancreas (mvAP) can help people with Type 1 Diabetes (T1DM) manage their blood sugar. The goal is for the mvAP to automatically adjust insulin based on meals, physical activity, and even stress, without you needing to manually input information. This is important because stress and different kinds of physical activity can make blood sugar levels hard to control. The study aims to see how well this mvAP can keep glucose levels stable. We are looking for 20 participants, aged 20 to 60, who have Type 1 Diabetes and use an insulin pump. You cannot join if you've had recent hospitalizations for diabetes complications or severe heart disease. The main goal is to measure your glucose concentration over two years.

Study design
This is an observational study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your glucose concentration will be measured for two years.

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NCT05145374

Multivariable Artificial Pancreas: Detecting and Mitigating Unannounced Physical Activity and Acute Psychological Stress

UNKNOWN
Not specifiedAges 20–60Observational
University of Illinois at Chicago
~20 participants
Updated 2024-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurement of Glucose Concentration
Measured over 2 years
Type 1 Diabetes
1 sites across 1 states
Illinois1
  • Ali Cinar · PRINCIPAL_INVESTIGATOR · Illinois Institute of Technology

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.
  • Measurement of Glucose Concentration2 years

    • Glucose concentration (mg/dl) will be measured by: Continuous Glucose Monitor