Assessing insulin infusion effectiveness in women with type 1 diabetes during their menstrual cycle
Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
This study tests how well an automatic insulin delivery system works for women with type 1 diabetes during different phases of their menstrual cycle.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 119 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06338072 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how automatic insulin infusion responds to changes in insulin sensitivity across different phases of the menstrual cycle in reproductive-aged women with type 1 diabetes. Utilizing an advanced closed-loop system, the study seeks to identify both the limitations and effectiveness of this technology in managing glycemic control. Insights gained will inform improvements in control algorithms and learning strategies within closed-loop systems, addressing unique challenges faced by women in diabetes management.
Who should consider this trial
Good fit: Ideal candidates include reproductive-aged women with type 1 diabetes who have regular menstrual cycles and are using the Medtronic Minimed 780G closed-loop system.
Not a fit: Patients who are pregnant, using hormonal contraceptives, or have serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance insulin management for women with type 1 diabetes, leading to better glycemic control during their menstrual cycles.
How similar studies have performed: While there is ongoing research in diabetes management, this specific focus on menstrual cycle effects in women using closed-loop systems is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid, Madrid
- Lía Nattero-Chávez — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Lía Nattero, MD.PhD — Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
- Study coordinator: Lía Nattero-Chávez, MD.PhD
- Email: marialia.nattero@salud.madrid.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.