CompletedNCT07865923SIESTAUpdated Oct 8, 2026

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

An interventional study of Structured Aerobic Exercise and Structured Resistance Exercise in Type 1 Diabetes (T1D), sponsored by National Council of Scientific and Technical Research, Argentina. Completed at 1 site in Argentina. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by National Council of Scientific and Technical Research, Argentina · Not applicable, Interventional, and Other

From the registry’s dates

Registered 2 years 6 months after the study started (first participant enrolled Mar 2024, registered Sep 2026).

Updated Oct 8, 2026Newly registeredGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Type 1 Diabetes (T1D)

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Keywords

Diabetes
Excercise
Stress
Glycemia
Remote monitoring
CGM
Glucose
Insulin

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

National Council of Scientific and Technical Research, Argentina is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 \<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.

Exclusion criteria

Exclusion Criteria:

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.
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.
Pregnant women, or women with the intention of getting pregnant; women breastfeeding.
Patient has been hospitalized for psychiatric treatment in the last 6 months.
Patient in treatment with psychiatric drugs.
Patient with a diagnosis or suspicion of an adrenal disease.
Patient has taken paracetamol 24 hours previous to the study.
Patient with uncontrolled arterial hypertension.
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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
Glucose monitoring under stress and exercise
Structured exercise and stress sessions to evaluate the effect of exercise and stress in glycemia and other signals.
Procedure: Structured Aerobic Exercise · Procedure: Structured Resistance Exercise · Procedure: Stress Test

Interventions

ProcedureStructured Aerobic Exercise
Structured exercise session designed to reach steady state of physical activity, predominantly aerobic.
ProcedureStructured Resistance Exercise
Structured exercise session designed as a series of resistance exercises, predominantly anaerobic.
ProcedureStress Test
Structured sessions based on the Trier Stress Social Test protocol.

What researchers measure

Primary outcomes

Changes in glycemia during stress and exercise
Glucose levels registered through continuous glucose monitoring (CGM) devices
Time frame: 4 weeks
Changes in HR during stress and exercise.
Heart rate recorded through an EMPATICA E4 device.
Time frame: 4 weeks
Changes in EDA during stress and exercise.
Electrodermal activity recorded through an EMPATICA E4 device.
Time frame: 4 weeks
Changes in TEMP during stress and exercise.
Skin temperature recorded through an EMPATICA E4 device.
Time frame: 4 weeks.
Accelerometer
Accelerometer signals recorded through an EMPATICA E4 device.
Time frame: 4 weeks

Study locations

1 site

Hospital Italiano de Buenos Aires
Buenos Aires, C1199ACL, Argentina

References and documents

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Apr 2024, 0 months.

Of 821 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 0 months is below that.

Counting every sponsor, half of 921 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 30, 2026
First posted: Oct 8, 2026
StartActual: Mar 5, 2024
Primary completionActual: Apr 1, 2024
CompletionActual: Jun 28, 2024
Last update: Oct 8, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 8, 2026

Show all 1 update

Oct 8, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07865923
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Collaborators: Hospital Italiano de Buenos Aires, Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata
Responsible party: Fabricio Garelli (Full Professor at National University of La Plata (UNLP) and Principal Researcher of CONICET, National Council of Scientific and Technical Research, Argentina) — Principal investigator
First posted: Oct 8, 2026
Start date: Mar 5, 2024
Primary completion: Apr 1, 2024
Completion: Jun 28, 2024
Last update: Oct 8, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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