CYCLUS. CYcle-tracking in Closed and open Loop Users for estimation of cycle- dependent variations in insulin Sensitivity. -A pilot study

Not Applicable

Recruiting

Conditions: Menstrual cycle in women with type 1 diabetes

Registration Number: DRKS00031941

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TIR – time in range<br>- Is defined as the percentage of glucose values between 70 mg/dl and 180 mg/dl.<br>- Data acquisition instruments:<br>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<br>- Timing: continuous data collection over 3 months

Secondary Outcome Measures

Name	Time	Method
TBR- time below range<br>TAR- time above range<br>coefficient of variation<br>- Data acquisition instruments:<br>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<br>- Timing: continuous data collection over 3 cycles<br><br>total daily insulin dose<br>- Measuring devices: Medtronic 640 G, Medtronic 670 G, Medtronic 770 G, Medtronic 780 G, Omnipod, Omnipod DASH, Ypsopump, smart insulin pen system.<br>- Time point: continuous daily data acquisition over 3 cycles