Status:

COMPLETED

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

Lead Sponsor:

University of Illinois at Chicago

Collaborating Sponsors:

Illinois Institute of Technology

University of Chicago

Conditions:

Type1 Diabetes Mellitus

Eligibility:

All Genders

18-60 years

Brief Summary

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 algor...

Detailed Description

The focus of the proposed work is to determine the most informative variables for meals, exercise, acute stress and sleep (MESS), identify select sensors that report these variables, and develop the a...

Eligibility Criteria

Inclusion

  • Men and Women with T1DM
  • 18-60 years of age
  • Insulin pump user

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.

Key Trial Info

Start Date :

May 24 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 13 2021

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT04725799

Start Date

May 24 2018

End Date

July 13 2021

Last Update

April 1 2022

Active Locations (1)

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University of Illinois at Chicago

Chicago, Illinois, United States, 60612