Menstrual cycle in women with type 1 diabetes
Conditions
Interventions
Group 1: 10 male participants with type 1 diabetes (13 to 30 years old)
Procedures
- Regular upload of sensor and pump data, for 6 months.
- Record keeping of alcohol consumption, exercise and illnes
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Age
13 Years to 30 Years
Inclusion criteria
Inclusion criteria: Age between 13 and 30 years (inclusive) T1D for at least 12 months Willing to use Auto mode or SmartGuard mode with target glucose of 100 mg/dl if available 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 Willing to download pump and isCGM/ rtCGM data at periodic intervals Willing to perform ovulation prediction test for female participants without contraceptive method Willing to perform a pregnancy test once a month Menarche occurred at least 2 years ago for female participants Sufficient language skills Sexual maturity rating 5 (TANNER stadium) for male participants In regular medical care at the Medical University Vienna or the Clinic Hietzing during the study periods Treated with faster-rapid acting insulin or rapid- acting insulin analogue
Exclusion criteria
Exclusion criteria: Pregnancy Breastfeeding Treatment with steroids/ immunosuppressant Severe psychiatric disorder Type 2 diabetes, type 3 diabetes or monogenic diabetes Progestin- only pills or levonorgestrel releasing intrauterine device as contraceptive method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TIR – time in range - Is defined as the percentage of glucose values between 70 mg/dl and 180 mg/dl. - Data acquisition instruments: Dexcom G6, Dexcom G7, Guardian 3 sensor, Guardian 4 sensor, EnLite sensor, Abbott FreeStyle Libre 1, Abbott FreeStyle Libre 2 or Abbott FreeStyle Libre 3 - Timing: continuous data collection over 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| TBR- time below range TAR- time above range coefficient of variation - Data acquisition instruments: Dexcom G6, Dexcom G7, Guardian 3 sensor, Guardian 4 sensor, EnLite sensor, Abbott FreeStyle Libre 1, Abbott FreeStyle Libre 2 or Abbott FreeStyle Libre 3 - Timing: continuous data collection over 3 cycles total daily insulin dose - Measuring devices: Medtronic 640 G, Medtronic 670 G, Medtronic 770 G, Medtronic 780 G, Omnipod, Omnipod DASH, Ypsopump, smart insulin pen system. - Time point: continuous daily data acquisition over 3 cycles | — |
Countries
Austria
Contacts
Public ContactKatrin Sophie Nagl
Medizinische Universität Wien
Outcome results
None listed