Type 1 DiabetesDIABETEXX/1NCT06338072
Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
An observational study of Type 1 Diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 119 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lía Nattero-Chávez, MD.PhD contact
Esther De la calle, MD. contact
Spain1 site, 1 recruiting
- Recruiting
Lía Nattero-Chávez
Madrid, Madrid, 28034
Lía Nattero-Chávez, 635249182, marialia.nattero@salud.madrid.org
Esther de La Calle, MD
About this study
Official title: Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (6)
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).
Measured: 1 month
Time above range
To assess the influence of menstrual cycle phases on time in above range (% of time >180 mg/dl of interstitial glucose).
Measured: 1 month
Caloric intake
To assess the influence of changes in intake throughout the menstrual cycle
Measured: 1 month
Temperature
To collect temperature using a wearable.
Measured: 1 month
Photoplethysmography
To collect photoplethysmography using a wearable.
Measured: 1 month
Accelerometry
To collect acelerometry using a wearable.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start3 Mar 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Sponsor
- Investigators
- Lía Nattero, MD.PhD, Principal investigator, Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338072
- Sponsor's protocol ID
- DIABETEXX/1
- Acronym
- DIABETEXX/1
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
- ClinicalTrials.gov ID
- NCT06338072
- Acronym / sponsor ID
- DIABETEXX/1 / DIABETEXX/1
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, close loop system, women
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Time below range
Time frame: 1 month
Time above range
Time frame: 1 month
Caloric intake
Time frame: 1 month
Temperature
Time frame: 1 month
Photoplethysmography
Time frame: 1 month
Accelerometry
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lía Nattero-Chávez, MD.PhD contact
Esther De la calle, MD. contact
Lía Nattero, MD.PhD principal investigator
Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lía Nattero-Chávez, MD.PhD (marialia.nattero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.