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| Name | Class |
|---|---|
| Universitat Politècnica de València | OTHER |
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The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult women of childbearing age using a loop system. | Adult women of childbearing age using the Minimed 780G loop system. Sixty-nine women of reproductive age will be recruited to assess variations in glycemic control across different stages of the menstrual cycle. Additionally, a subset of these women (n = 50) will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data. | ||
| Adult men under 50 years old using a closed loop system. | A control group of 50 men will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time in range | To assess the influence of menstrual cycle phases on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time below range | To assess the influence of menstrual cycle phases on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose). | 1 month |
| Time above range |
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Inclusion Criteria:
Exclusion Criteria:
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Sixty-nine women of reproductive age will be recluted to investigate fluctuations in glycemic control throughout the menstrual cycle. Furthermore, a subgroup comprising 50 of these women, along with a control group consisting of 50 men, will wear a wearable device to gather temperature, photoplethysmography, and accelerometry data
Patients of both genders, aged 18 or older, with type 1 diabetes and in their reproductive years, receiving care at the Endocrinology and Nutrition Department of Ramón y Cajal University Hospital in Madrid, and undergoing treatment with the Medtronic© MinimedTM 780G closed loop advanced system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lía Nattero-Chávez, MD.PhD | Contact | marialia.nattero@salud.madrid.org | ||
| Esther De la calle, MD. | Contact | esther.delacalle@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Lía Nattero, MD.PhD | Diabetes, Obesity and Human Reproduction Research Group (IRYCIS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lía Nattero-Chávez | Recruiting | Madrid | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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To assess the influence of menstrual cycle phases on time in above range (% of time >180 mg/dl of interstitial glucose).
| 1 month |
| Caloric intake | To assess the influence of changes in intake throughout the menstrual cycle | 1 month |
| Temperature | To collect temperature using a wearable. | 1 month |
| Photoplethysmography | To collect photoplethysmography using a wearable. | 1 month |
| Accelerometry | To collect acelerometry using a wearable. | 1 month |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |