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Completed NCT07865923

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

Conditions: Type 1 Diabetes (T1D)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: National Council of Scientific and Technical Research, Argentina

Location: Hospital Italiano de Buenos Aires Buenos Aires

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.

Eligibility Criteria

Inclusion Criteria: * Patient has been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit. * Patient is \>18 and \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07865923). StuddyBuddy aggregates publicly available trial information.