US University studies Additional Signals for Exercise, Stress and Sleep and Prediction of Glucose Levels for AP Systems

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The University of Illinois at Chicago is starting a new clinical trial of Additional Signals for Exercise, Stress and Sleep and Prediction of Glucose Levels for AP Systems.

The objective of this research is to determine the most informative variables for detecting exercise, acute stress and sleep, identify select sensors that report these variables, and develop the algorithms to detect the occurrence of exercise, stress and sleep, to discriminate them and to determine their characteristics. Research is needed to identify which wearable devices report the most informative and predictive variables of exercise, acute stress and sleep with desired precision and accuracy, determine the best location to wear them for collecting reliable and informative data, and to distill accurate knowledge from data reported by wearable sensors. Data and their interpretation should be informative for various types of physical activities, stages of sleep, and types and intensities of acute stress, and concurrent occurrence of these factors. The investigators will use several devices (chest band, wristband and skin patches) to collect data and evaluate their information content and contribution to improvement of glucose concentration prediction, best locations for collecting accurate and reliable information by conducting clinical and free-living experiments at-home to assess the contributions of the wearable device in improving the accuracy of glucose concentration prediction and the performance of the multivariable artificial pancreas.

The clinical trial started in May 24, 2018 and will continue throughout September 1, 2021.

The excluding condition are:

• 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.

The contacts and locations are the University of Illinois at Chicago, Chicago, Illinois, United States.

For more details: https://ichgcp.net/clinical-trials-registry/NCT04725799