Diabetes Mellitus, Type 1
Conditions
Keywords
Menstrual cycle, Trajectories, Women, Insulin sensitivity, Glycaemia, Insulin need
Brief summary
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
OTHERNo intervention
Observational prospective longitudinal data collection
Sponsors
The Danish Diabetes Association
Heart and Diabetes Center North Rhine-Westphalia
University of Bristol
Emory University
DCB Research AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify clusters in trajectories across the menstrual cycle | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness. | 6 months | 2\. Manual Insulin Adjustment Techniques: * Frequency and classification (e.g., timing, magnitude) of manual insulin adjustments. * Impact of adjustment techniques on glycemic outcomes. |
| To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle | 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) |
| To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints. | 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. |
Countries
Switzerland
Contacts
Primary ContactStefanie Hossmann, MSc
Backup ContactMartina Rothenbühler, PhD
Outcome results
None listed