Recruiting NCT06282055
Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes
Overview
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.
Interventions
- Other No intervention
Observational prospective longitudinal data collection
Primary outcome measures
- Identify clusters in trajectories across the menstrual cycle [Time frame: 6 months]
Secondary outcome measures (3)
- To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness. [Time frame: 6 months]
- To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle [Time frame: 6 months]
- To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints. [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- DCB Research AG — Bern
Identifiers
NCT: NCT06282055 · TIMES