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NCT Number: NCT06729242

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

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.

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Key information

Conditions

Diabetes Mellitus, Type I Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Menstruation Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, Select One, 46010, Spain

Location status: Recruiting

Location contact

Rodrigo

CONTACT

[email protected]

963983855

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aerobic session

Other

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

HIIT session

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Oestrogens

    Time frame: pre-intervention

    Estradiol levels (pg/ml) will be measured through blood extractions and subsequent analysis in the laboratory.

  2. Progesterone

    Time frame: Pre-intervention

    Progesterone (ng/mL) will be measured through blood extractions and subsequent analysis in the laboratory.

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Martín-San Agustín, Dr.

CONTACT

[email protected]

0034963983855

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • European Regional Development Fund

Registry information

Official study title

Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)

Acronym: DIABETEXX/2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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