Clinical trial Recruiting at 1 site Interventional Ages 18 to 45 Women only

How menstrual cycle phases affect blood sugar during aerobic and HIIT exercise in women with Type 1 diabetes.

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)

Run by University of Valencia · NCT06729242 · Data updated 2026-11-12

This study will test whether blood sugar responds differently to aerobic exercise versus high-intensity interval training at different menstrual cycle phases in adult women with Type 1 diabetes.

More Diabetes Mellitus, Type I trials

Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment40 (estimated)
SponsorUniversity of Valencia
Academic / other
Locations1 site (Valencia, Select One)
StatusRecruiting
StartedJanuary 10, 2025
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedJuly 8, 2025
Trial IDNCT06729242 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are menstruating women aged 18–45 with Type 1 diabetes for more than 2 years, HbA1c under 8.5%, a stable insulin regimen (MDI or pump) for the past 6 months, and who do at least 90 minutes of weekly physical activity but are not competitive athletes.

Probably not a fit

Women who are not menstruating (including post‑menopausal or pregnant), those using medications that affect glycemia (e.g., systemic steroids or metformin), or with unstable insulin dosing or HbA1c above 8.5% are less likely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses continuous glucose monitors to record blood glucose responses in adult women with Type 1 diabetes during standardized aerobic and high-intensity interval training sessions. Sessions will be scheduled in different menstrual cycle phases to compare glucose behavior for each exercise type and phase. Researchers will model glucose trajectories and insulin adjustments to identify patterns linked to cycle phases. Results will be used to create exercise programming guidelines and to inform artificial pancreas algorithms that account for menstrual-cycle effects.

Why it matters

Potential benefit: If successful, the results could help personalize exercise advice and improve glucose control for menstruating women with Type 1 diabetes and inform better artificial pancreas settings.

How similar studies have gone: Small prior studies suggest menstrual phase can change glucose responses to exercise, but direct comparisons of aerobic versus HIIT across cycle phases and incorporation into closed‑loop systems remain limited and partly novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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.

Exclusion Criteria:

Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).

Where it's running

  • University of Valencia
    Valencia, Select One, Spain
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.