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COMPLETED
NCT07865923
NA

Clinical Trial for the Study of Stress and Exercise Impact on Glucose Levels and Additional Physiological Signals. Stress, Insulin and Exercise Study: a Trial in Argentina

Sponsor: National Council of Scientific and Technical Research, Argentina

View on ClinicalTrials.gov

Summary

The study lasted 28 days. During the study period, participants completed two structured aerobic exercise sessions (days 4 and 18), two structured resistance exercise sessions (days 11 and 25), and four structured stress tests (days 3, 10, 19, and 24). In addition to these structured sessions, participants were instructed to record events occurring in their daily lives, including meals consumed, physical activity (both planned and unplanned), and stressful situations experienced. Blood glucose levels were continuously monitored using a Dexcom ONE Continuous Glucose Monitor (CGM). An Empatica E4 wristband was used to non-invasively collect physiological variables, while an Android smartphone with the Insumate application installed was used to monitor and record daily activities. Insulin delivery information was obtained from the participants' own insulin pumps. The study protocol was reviewed and approved by the Ethics Committee of the Hospital Italiano de Buenos Aires (HIBA) under registration code No. 11719.

Official title: Evaluation of Continuous Glucose Monitoring Under Exercise and Stress Conditions to Model Glycemic Changes in Ambulatory Patients With Type 1 Diabetes.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2024-03-05

Completion Date

2024-06-28

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

PROCEDURE

Structured Aerobic Exercise

Structured exercise session designed to reach steady state of physical activity, predominantly aerobic.

PROCEDURE

Structured Resistance Exercise

Structured exercise session designed as a series of resistance exercises, predominantly anaerobic.

PROCEDURE

Stress Test

Structured sessions based on the Trier Stress Social Test protocol.

Locations (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina