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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorDCB Research AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial population

People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Observational prospective longitudinal data collection

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Women with T1D1 intervention

Trial outcomes

Primary outcomes

1

Identify clusters in trajectories across the menstrual cycle

1. Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints). 2. 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) 3. Insulin administration measures across the menstrual cycle/menstrual cycle phases: * Basal and bolus insulin dosage * Total daily dose (TDD) * Basal/bolus ratio

Time frame
6 months

Secondary outcomes

1

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

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

Time frame
6 months
2

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

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)

Time frame
6 months
3

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

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DCB Research AG

Lead sponsor

The Danish Diabetes Association

Collaborator

Heart and Diabetes Center North Rhine-Westphalia

Collaborator

University of Bristol

Collaborator

Emory University

Collaborator