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

Type 1 Diabetes Clinical Trial

— DIABETEXX/1  

Official title:

Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06338072
• Other study ID #: DIABETEXX/1
• Status: Active, not recruiting
• Start date: March 3, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: August 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Spain	Lía Nattero-Chávez	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Universitat Politècnica de València

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time above range	To assess the influence of menstrual cycle phases on time in above range (% of time >180 mg/dl of interstitial glucose).	1 month
Secondary	Caloric intake	To assess the influence of changes in intake throughout the menstrual cycle	1 month
Secondary	Temperature	To collect temperature using a wearable.	1 month
Secondary	Photoplethysmography	To collect photoplethysmography using a wearable.	1 month
Secondary	Accelerometry	To collect acelerometry using a wearable.	1 month