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

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06338072
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-03
• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-03-23
• Study First Posted: 2024-03-29
• Status Verified: 2024-04
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Caloric intake	1 month	To assess the influence of changes in intake throughout the menstrual cycle
Temperature	1 month	To collect temperature using a wearable.
Photoplethysmography	1 month	To collect photoplethysmography using a wearable.
Accelerometry	1 month	To collect acelerometry using a wearable.
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).
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).

Trial Locations

Locations (1)

Lía Nattero-Chávez; 🇪🇸 Madrid, Spain