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NCT Number: NCT06282055

Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes

Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female sex
  • Between 18 and 40 years at inclusion
  • Menarche at least one year prior to study inclusion
  • Regular menstrual cycle (at least one menstrual cycle in the last 40 days)
  • Average menstrual cycle length between 21 and 38 days
  • Difference in length between consecutive menstrual cycles of at most 7 days
  • Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year
  • Actively using an AID system for their diabetes management at least six months prior to study inclusion

Exclusion criteria

  • Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
  • Pregnancy until two months postpartum (ongoing or planned)
  • Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
  • Known Polycystic Ovary Syndrome (PCOS)
  • Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs
  • Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis).
  • Participation in an interventional study within two months preceding and during the present study

Treatment and study plan

No intervention

Other

Observational prospective longitudinal data collection

Primary outcomes

  1. Identify clusters in trajectories across the menstrual cycle

    Time frame: 6 months

    • Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints).
    • Glycemia measures across the menstrual cycle/menstrual cycle phases:
    • Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV)
    • Mean glucose and mean fasted glucose
    • High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI)
    • Insulin administration measures across the menstrual cycle/menstrual cycle phases:
    • Basal and bolus insulin dosage
    • Total daily dose (TDD)
    • Basal/bolus ratio

Secondary outcomes

  1. To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.

    Time frame: 6 months

    • Manual Insulin Adjustment Techniques:
    • Frequency and classification (e.g., timing, magnitude) of manual insulin adjustments.
    • Impact of adjustment techniques on glycemic outcomes.

  2. To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle

    Time frame: 6 months

    Identification and characterization of distinct clusters in glycemic metrics, insulin administration and insulin sensitivity representing unique patterns across distinct menstrual cycle phases (early follicular phase, late follicular phase, peri-ovulation, early luteal, mid luteal and late luteal phase)

  3. To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.

    Time frame: 6 months

    Predictive Factors:

    o Identification of demographic, clinical, or physiological predictors (e.g., premenstrual cycle syndrome (PMS) score or age group) that significantly correlate with primary outcomes.

Study contacts

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

Martina Rothenbühler, PhD

CONTACT

[email protected]

Stefanie Hossmann, MSc

CONTACT

[email protected]

+41794217376

Sponsors and collaborators

Lead sponsor

DCB Research AG

Other

Collaborators

  • Emory University
  • Heart and Diabetes Center North Rhine-Westphalia
  • The Danish Diabetes Association
  • University of Bristol

Registry information

Acronym: TIMES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Dec 3, 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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