Diabetes Mellitus, Type IDIABETEXX/2NCT06729242
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
A study testing Aerobic session and HIIT session in people with Diabetes Mellitus, Type I and Menstruation, run by University of Valencia at 1 site in Spain.
Trial summary
Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type I, Menstruation
- What is being tested?
- Aerobic session and HIIT session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2025to Jun 2026
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) < 8.5% (<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.
Who cannot join
- Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, Select One, 46010
Rodrigo, 963983855, rodrigo.martin@uv.es
About this study
Official title: Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)
Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.
- Conditions
- Diabetes Mellitus, Type I, Menstruation
- Being tested
- Aerobic session, HIIT session
- 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.
Aerobic sessionOther
This session will consist of an aerobic training session performed on a cycle ergometer.
HIIT sessionOther
The HIIT exercise will consist of strength exercises with elastic bands.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic session in luteal phase first menstruation | Experimental | The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 21 of first menstruation. Receives: Other: Aerobic session |
| Aerobic session in follicular phase first menstruation | Experimental | The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 3 of menstruation. Receives: Other: Aerobic session |
| Aerobic session in luteal phase second menstruation | Experimental | The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 21 of second menstruation. Receives: Other: Aerobic session |
| HIIT session in luteal phase first menstruation | Experimental | The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of first menstruation. Receives: Other: HIIT session |
| HIIT session in follicular phase first menstruation | Experimental | The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 3 of first menstruation. Receives: Other: HIIT session |
| HIIT session in luteal phase second menstruation | Experimental | The HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of second menstruation. Receives: Other: HIIT session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean interstitial glucose
Mean interstitial glucose (mg/dL) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Measured: 24 hours pre-intervention and 24 hours post-intervention
Glycemic variability
Glycemic variability (measured using the Coefficient of Variation-CV) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Measured: 24 hours pre-intervention and 24 hours post-intervention
Time spent at each glucose range
Time spent at each glucose range [euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (>250 mg/dL)] will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Measured: 24 hours pre-intervention and 24 hours post-intervention
Secondary outcomes (2)
Oestrogens
Estradiol levels (pg/ml) will be measured through blood extractions and subsequent analysis in the laboratory.
Measured: pre-intervention
Progesterone
Progesterone (ng/mL) will be measured through blood extractions and subsequent analysis in the laboratory.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start10 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Six interventions will be carried out in a single group, being three aerobic sessions, two in two luteal phases and another in follicular phase, and other three session of high intensity interval exercise (HIIT).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729242
- Sponsor's protocol ID
- 2024.228
- Other IDs
- PID2022-137723OB-C21
- Acronym
- DIABETEXX/2
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)
- ClinicalTrials.gov ID
- NCT06729242
- Acronym / sponsor ID
- DIABETEXX/2 / 2024.228
- Conditions
- Diabetes Mellitus, Type I, Menstruation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- European Regional Development Fund
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Dec 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.
Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Six interventions will be carried out in a single group, being three aerobic sessions, two in two luteal phases and another in follicular phase, and other three session of high intensity interval exercise (HIIT).
| Arm | Type | Receives |
|---|---|---|
| Aerobic session in luteal phase first menstruation | Experimental | Other: Aerobic sessionThe aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 21 of first menstruation. |
| Aerobic session in follicular phase first menstruation | Experimental | Other: Aerobic sessionThe aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 3 of menstruation. |
| Aerobic session in luteal phase second menstruation | Experimental | Other: Aerobic sessionThe aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 40 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. This session will be held on day 21 of second menstruation. |
| HIIT session in luteal phase first menstruation | Experimental | Other: HIIT sessionThe HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of first menstruation. |
| HIIT session in follicular phase first menstruation | Experimental | Other: HIIT sessionThe HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 3 of first menstruation. |
| HIIT session in luteal phase second menstruation | Experimental | Other: HIIT sessionThe HIIT exercise will consist of strength exercises with elastic bands. The session consists of two sets of exercise intervals of 20 s separated by 10 s of rest (i.e. 4 min in total) with a rest of 3 minutes between each set, performing in each interval a different exercise resisted by the elastic band. This session will be held on day 21 of second menstruation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) < 8.5% (<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.
Key exclusion criteria (1 listed)
- Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic sessionThis session will consist of an aerobic training session performed on a cycle ergometer. | Other | Aerobic session in follicular phase first menstruation, Aerobic session in luteal phase first menstruation, Aerobic session in luteal phase second menstruation |
| HIIT sessionThe HIIT exercise will consist of strength exercises with elastic bands. | Other | HIIT session in follicular phase first menstruation, HIIT session in luteal phase first menstruation, HIIT session in luteal phase second menstruation |
Primary outcome
Mean interstitial glucose
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Mean interstitial glucose (mg/dL) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Glycemic variability
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Glycemic variability (measured using the Coefficient of Variation-CV) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
Time spent at each glucose range
Time frame: 24 hours pre-intervention and 24 hours post-intervention
Time spent at each glucose range [euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (>250 mg/dL)] will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions.
2 secondary outcomes
Oestrogens
Time frame: pre-intervention
Progesterone
Time frame: Pre-intervention
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 8 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type I
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic session and HIIT session in people with Diabetes Mellitus, Type I and Menstruation, run by University of Valencia 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 1 inclusion and 1 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 8 Jul 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 Rodrigo Martín-San Agustín, Dr. (0034963983855, rodrigo.martin@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean interstitial glucose (time frame: 24 hours pre-intervention and 24 hours post-intervention). The study lists 3 primary outcomes in all. 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 8 Jul 2025.