NCT07865923Completed
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
Evaluation of Continuous Glucose Monitoring Under Exercise and Stress Conditions to Model Glycemic Changes in Ambulatory Patients With Type 1 Diabetes.
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 30 Sept 2026
- Start date
- 5 Mar 2024
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Diseases
- Type 1 diabetes
- NCT number
- NCT07865923
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 5 Mar 2024 to the primary completion date, 1 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient in treatment with psychiatric drugs.
- Patient has taken paracetamol 24 hours previous to the study.
- Patient has a history of coronary disease or cardiac failure and/or an episode of acute decompensation within the 6 months prior to the study.
Other illness
- Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia.
- Patient has symptoms compatible with an active infectious disease.
- Patient has been hospitalized for psychiatric treatment in the last 6 months.
- Patient with a diagnosis or suspicion of an adrenal disease.
- Patient with uncontrolled arterial hypertension.
Other
- Patient has been hospitalized for diabetic ketoacidosis in the last 6 months.
- Patient has experienced severe hypoglycemia with loss of consciousness in the last 6 months.
- Pregnant women, or women with the intention of getting pregnant; women breastfeeding.
Who the study is looking for
- 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 \<65 years.
- Patient has HbA1c \< 10%.
- Woman in premenopausal age who use contraceptive methods.
- Woman in premenopausal age has negative B-HCG in the tests performed in the trial.
- Patient is trained in carbohydrates counting.
- Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.