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

NCT05145374 | Recruiting DMC

• 1 other identifier: 2021-0415
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this proposal is to demonstrate a viable, functionally integrated multivariable artificial pancreas (mvAP) that will address meal, physical activity (PA) and acute psychological stress (APS) challenges without any manual inputs to better regulate glucose levels of people with diabetes. Acute psychological stress and many other forms of PA besides planned exercise can affect blood glucose levels and cause challenges to maintaining euglycemia for people with type 1 diabetes mellitus (T1DM). Various PA and APS affect the metabolism and sensitivity to insulin in different ways. Hence, their types, intensities and durations, and their individual and concurrent presence must be detected in order to determine the optimal insulin administration. The mvAP approach provides a well-integrated and user-friendly technology with minimal burden on the user and mitigates the effects of unexpected PA and APS inducements. Twenty subjects with type 1 diabetes (ages 18-60) who use insulin pumps enrolled in this study. The study will take place at the UIC-College of Nursing Diabetes and Exercise Laboratory. The protocol will include 1 screening visit and 5 sessions at the laboratory. The primary activities at each meeting will include: (1) screening; (2) measurement of peak exercise capacity; (3) estimation of maximal strength from submaximal strength tests; (4) Trier Social Stress Test; (5) submaximal bouts of aerobic and resistance exercise, and activities of daily living with and without stress (e.g., mental calculations, video games). These activities will be included visit 3, 4 and 5 as appropriate. In addition, subjects will perform activities at home include: housekeeping chores, stationary bike (if available); treadmill (if available); walking; and light weights (if available). Periodically, the research assistant will call the subject during these times and ask them to perform stress-inducing activities while performing the activity. The stress inducing activities will include mental challenges such as a mathematical computation while performing the activity. The subjects will be called at home 3-5 times during the study. The fully automated algorithm will be tested in a home setting, however, the methodology will be developed and approved for testing later in the study.

Conditions

Type 1 Diabetes

Keywords

Physical Activity; Psychological Stress; Artificial Pancreas; Sleep; Stress

Outcome Measures

Primary Outcomes (1)

• Measurement of Glucose Concentration

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

  2 years

Study Arms (1)

Stressful Stimuli

Participation in meal, exercise, sleep activities alone or in combination with stressful stimuli.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and Women with Type 1 Diabetes

You may qualify if:

• Men and Women with T1DM
• Insulin pump users

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Illinois Institute of Technology: collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (5)

• Sevil M, Rashid M, Hajizadeh I, Askari MR, Hobbs N, Brandt R, Park M, Quinn L, Cinar A. Discrimination of simultaneous psychological and physical stressors using wristband biosignals. Comput Methods Programs Biomed. 2021 Feb;199:105898. doi: 10.1016/j.cmpb.2020.105898. Epub 2020 Dec 17.

  PMID: 33360529 BACKGROUND

• Sevil M, Rashid M, Maloney Z, Hajizadeh I, Samadi S, Askari MR, Hobbs N, Brandt R, Park M, Quinn L, Cinar A. Determining Physical Activity Characteristics from Wristband Data for Use in Automated Insulin Delivery Systems. IEEE Sens J. 2020 Nov;20(21):12859-12870. doi: 10.1109/jsen.2020.3000772. Epub 2020 Jun 8.

  PMID: 33100923 BACKGROUND

• Rashid M, Samadi S, Sevil M, Hajizadeh I, Kolodziej P, Hobbs N, Maloney Z, Brandt R, Feng J, Park M, Quinn L, Cinar A. Simulation Software for Assessment of Nonlinear and Adaptive Multivariable Control Algorithms: Glucose - Insulin Dynamics in Type 1 Diabetes. Comput Chem Eng. 2019 Nov 2;130:106565. doi: 10.1016/j.compchemeng.2019.106565. Epub 2019 Sep 2.

  PMID: 32863472 BACKGROUND

• Turksoy K, Hajizadeh I, Hobbs N, Kilkus J, Littlejohn E, Samadi S, Feng J, Sevil M, Lazaro C, Ritthaler J, Hibner B, Devine N, Quinn L, Cinar A. Multivariable Artificial Pancreas for Various Exercise Types and Intensities. Diabetes Technol Ther. 2018 Oct;20(10):662-671. doi: 10.1089/dia.2018.0072. Epub 2018 Sep 6.

  PMID: 30188192 BACKGROUND

• Brandt R, Park M, Wroblewski K, Quinn L, Tasali E, Cinar A. Sleep quality and glycaemic variability in a real-life setting in adults with type 1 diabetes. Diabetologia. 2021 Oct;64(10):2159-2169. doi: 10.1007/s00125-021-05500-9. Epub 2021 Jun 17.

  PMID: 34136937 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Stress, Psychological

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Behavioral Symptoms

Study Officials

• Ali Cinar

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Quinn, PhD

CONTACT

3127716497; lquinn1@uic.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 6, 2021
• Study Start: July 1, 2022
• Primary Completion: July 15, 2025
• Study Completion: September 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)