Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, close loop system, women
Brief summary
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.
Interventions
None listed
Sponsors
Universitat Politècnica de València
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Inclusion criteria
* Diagnostic criteria for DM1 according to ADA * Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system. * Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year. * Men under 50 years old. * Acceptance of participation in the study and signing of the informed consent
Exclusion criteria
* Gestation * Use of hormonal contraceptives (including intrauterine devices) * Institutionalization, serious or terminal illness or renal replacement therapy. * Refusal to participate in the study or to sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time above range | 1 month | To assess the influence of menstrual cycle phases on time in above range (% of time \>180 mg/dl of interstitial glucose). |
| Caloric intake | 1 month | To assess the influence of changes in intake throughout the menstrual cycle |
| Time below range | 1 month | 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). |
| Photoplethysmography | 1 month | To collect photoplethysmography using a wearable. |
| Accelerometry | 1 month | To collect acelerometry using a wearable. |
| Temperature | 1 month | To collect temperature using a wearable. |
Countries
Spain
Contacts
Primary ContactLía Nattero-Chávez, MD.PhD
Backup ContactEsther De la calle, MD.
Outcome results
None listed