Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).

NCT06338072 | Recruiting

• 1 other identifier: DIABETEXX/1
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, close loop system, women

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Time below range

  1 month

• Time above range

  1 month

• Caloric intake

  1 month

• Temperature

  1 month

• Photoplethysmography

  1 month

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 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
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Lía Nattero-Chávez

Madrid, Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lía Nattero, MD.PhD

  Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lía Nattero-Chávez, MD.PhD

CONTACT

marialia.nattero@salud.madrid.org

Esther De la calle, MD.

CONTACT

esther.delacalle@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: March 3, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

ES (1)