Lía Nattero-Chávez
Madrid, 28034, Spain
Location status: Recruiting
Location contact
Esther de La Calle, MD
PRINCIPAL_INVESTIGATOR
Lía Nattero Chávez, MD.PhD
PRINCIPAL_INVESTIGATOR
Lía Nattero-Chávez
CONTACT
Recruiting
NCT Number: NCT06338072
Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Time in range
Time frame: 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 outcomes
-
Time below range
Time frame: 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).
-
Time above range
Time frame: 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
Time frame: 1 month
To assess the influence of changes in intake throughout the menstrual cycle
-
Temperature
Time frame: 1 month
To collect temperature using a wearable.
-
Photoplethysmography
Time frame: 1 month
To collect photoplethysmography using a wearable.
-
Accelerometry
Time frame: 1 month
To collect acelerometry using a wearable.
Study contacts
Contact information is provided by the study sponsor or research team.
Esther De la calle, MD.
CONTACT
Lía Nattero-Chávez, MD.PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Other
Collaborators
- Universitat Politècnica de València
Registry information
Official study title
Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
Acronym: DIABETEXX/1
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 29, 2024
- Registry last updated
- Aug 7, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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