Type 1 Diabetes (T1D)
Conditions
Keywords
Diabetes, Excercise, Stress, Glycemia, Remote monitoring, CGM, Glucose, Insulin
Brief 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.
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.
Sponsors
National Council of Scientific and Technical Research, Argentina
Hospital Italiano de Buenos Aires
Instituto Tecnológico de Buenos Aires
Universidad Nacional de La Plata
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycemia during stress and exercise | 4 weeks | Glucose levels registered through continuous glucose monitoring (CGM) devices |
| Changes in HR during stress and exercise. | 4 weeks | Heart rate recorded through an EMPATICA E4 device. |
| Changes in EDA during stress and exercise. | 4 weeks | Electrodermal activity recorded through an EMPATICA E4 device. |
| Changes in TEMP during stress and exercise. | 4 weeks. | Skin temperature recorded through an EMPATICA E4 device. |
| Accelerometer | 4 weeks | Accelerometer signals recorded through an EMPATICA E4 device. |
Countries
Argentina
Outcome results
None listed