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Clinical Trials in Spain / NCT06729242
Recruiting Not applicable

Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes

NCT06729242 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Valencia
Phase
Not applicable
Started
2025-01-10
Last updated
2025-07-08

Condition(s) studied

Diabetes Mellitus, Type IMenstruation

Investigational drug(s) / intervention(s)

Aerobic sessionHIIT session

Aerobic session: This session will consist of an aerobic training session performed on a cycle ergometer.

HIIT session: The HIIT exercise will consist of strength exercises with elastic bands.

Study 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. 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Mean interstitial glucose — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Valencia Valencia Select One Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06729242 on ClinicalTrials.gov ↗ ← All trials in Spain