E10
Conditions
Interventions
Group 1: 60 female participants with regular cycles (aged 14 to 40)
Examinations and Surveys:
- Regular upload of CGM and pump data for 3 cycles
- Cycle tracking via menstrual app, daily during menst
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
Female
Age
14 Years to 40 Years
Inclusion criteria
Inclusion criteria: Age between 14 and 40 years (inclusive) T1D for at least 12 months Willing to use an insulin pump with continuous glucose monitoring (commercially available open loop system or hybrid closed loop system) or a smart insulin pen Willing to use isCGM/ rtCGM for more than 70% of time Willing to use Auto mode or SmartGuard mode, if using a respective pump Willing to download and send pump and isCGM/ rtCGM data at periodic intervals Willing to use Auto mode or SmartGuard mode with target glucose of 100 mg/dl if available Willing to perform ovulation prediction test for participants without hormonal contraceptive method Willing to take saliva samples for participants without hormonal contraceptive method Willing to perform a pregnancy test once a month Menarche occurred at least 2 years ago Sufficient language skills (English or German) Treated with faster-rapid acting insulin or rapid- acting insulin analogue
Exclusion criteria
Exclusion criteria: Pregnancy Breastfeeding Treatment with systemic corticosteroids (including testosterone)/ immunosuppressant (inhalative or topical corticosteroids are not exclusion criteria) Severe psychiatric disorder endangering adherence to study protocol (suicidal behavior, severe personality disorders) Type 2 diabetes, type 3 diabetes or monogenic diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean glucose level - Data collection instruments: Dexcom G6, Dexcom G7, Guardian 3 sensor, Guardian 4 sensor, EnLite sensor, Abbott FreeStyle Libre 1, Abbott FreeStyle Libre 2, Abbott FreeStyle Libre 3, Simplera - Time point: continuous survey over 3 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Time in range (proportion of glucose values between 70 mg/dl and 180 mg/dl) Time below range Time above range Time in tight range Coefficient of variation/glucose variability - Survey instruments: Dexcom G6, Dexcom G7, Guardian 3 sensor, Guardian 4 sensor, EnLite sensor, Abbott FreeStyle Libre 1, Abbott FreeStyle Libre 2, Abbott FreeStyle Libre 3, Simplera - Time point: continuous collection over 3 cycles Insulin dose/kg bodyweight - Data collection instruments: insulin pumps, Smartpen - Time point: continuous survey over 3 cycles | — |
Countries
Austria
Contacts
Public ContactKatrin Sophie Nagl
Medizinische Universität Wien
Outcome results
None listed