Type 1 Diabetes (T1D)SIESTANCT07865923
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
A study testing Structured Aerobic Exercise, Structured Resistance Exercise and Stress Test in people with Type 1 Diabetes (T1D), run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Structured Aerobic Exercise, Structured Resistance Exercise and Stress Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteArgentina
- Study dates
- 5 Mar 2024to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Continuous Glucose Monitoring Under Exercise and Stress Conditions to Model Glycemic Changes in Ambulatory Patients With Type 1 Diabetes.
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
- Type 1 Diabetes (T1D)
- Being tested
- Structured Aerobic Exercise, Structured Resistance Exercise, Stress Test
- Keywords
- Diabetes, Excercise, Stress, Glycemia, Remote monitoring, CGM, Glucose, Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Aerobic ExerciseProcedure or surgery
Structured exercise session designed to reach steady state of physical activity, predominantly aerobic.
Structured Resistance ExerciseProcedure or surgery
Structured exercise session designed as a series of resistance exercises, predominantly anaerobic.
Stress TestProcedure or surgery
Structured sessions based on the Trier Stress Social Test protocol.
| Study group | Role | What they receive |
|---|---|---|
| Glucose monitoring under stress and exercise | Experimental | Structured exercise and stress sessions to evaluate the effect of exercise and stress in glycemia and other signals. Receives: Procedure: Structured Aerobic Exercise; Procedure: Structured Resistance Exercise; Procedure: Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycemia during stress and exercise
Glucose levels registered through continuous glucose monitoring (CGM) devices
Measured: 4 weeks
Changes in HR during stress and exercise.
Heart rate recorded through an EMPATICA E4 device.
Measured: 4 weeks
Changes in EDA during stress and exercise.
Electrodermal activity recorded through an EMPATICA E4 device.
Measured: 4 weeks
Changes in TEMP during stress and exercise.
Skin temperature recorded through an EMPATICA E4 device.
Measured: 4 weeks.
Accelerometer
Accelerometer signals recorded through an EMPATICA E4 device.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start5 Mar 2024
- Primary completion1 Apr 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Collaborators
- Hospital Italiano de Buenos Aires, Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata
- Responsible party
- Principal investigator, Fabricio Garelli, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865923
- Sponsor's protocol ID
- CEPI HIBA 11719
- Acronym
- SIESTA
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Continuous Glucose Monitoring Under Exercise and Stress Conditions to Model Glycemic Changes in Ambulatory Patients With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT07865923
- Acronym / sponsor ID
- SIESTA / CEPI HIBA 11719
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Diabetes, Excercise, Stress, Glycemia, Remote monitoring, CGM, Glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Collaborators
- Hospital Italiano de Buenos Aires, Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucose monitoring under stress and exercise | Experimental | Procedure: Structured Aerobic Exercise, Procedure: Structured Resistance Exercise, Procedure: Stress TestStructured exercise and stress sessions to evaluate the effect of exercise and stress in glycemia and other signals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Aerobic ExerciseStructured exercise session designed to reach steady state of physical activity, predominantly aerobic. | Procedure or surgery | Glucose monitoring under stress and exercise |
| Structured Resistance ExerciseStructured exercise session designed as a series of resistance exercises, predominantly anaerobic. | Procedure or surgery | Glucose monitoring under stress and exercise |
| Stress TestStructured sessions based on the Trier Stress Social Test protocol. | Procedure or surgery | Glucose monitoring under stress and exercise |
Primary outcome
Changes in glycemia during stress and exercise
Time frame: 4 weeks
Glucose levels registered through continuous glucose monitoring (CGM) devices
Changes in HR during stress and exercise.
Time frame: 4 weeks
Heart rate recorded through an EMPATICA E4 device.
Changes in EDA during stress and exercise.
Time frame: 4 weeks
Electrodermal activity recorded through an EMPATICA E4 device.
Changes in TEMP during stress and exercise.
Time frame: 4 weeks.
Skin temperature recorded through an EMPATICA E4 device.
Accelerometer
Time frame: 4 weeks
Accelerometer signals recorded through an EMPATICA E4 device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Study Dataset (Physiological signals)Link provided by the sponsor.
- Study Dataset (Glucose, insulin and events)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Aerobic Exercise, Structured Resistance Exercise and Stress Test in people with Type 1 Diabetes (T1D), run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycemia during stress and exercise (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.