The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Measurements of interstitial glucose variations with FreeStyle Libre Pro
CHU de Besançon
Besançon, France
Incidence rate of hyperglycemia
In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows: * if diabetes de novo: * capillar or interstitial fasting blood glucose ≥ 1,50 g/L, * OR postprandial interstitial glucose ≥ 2 g/L * OR glucose monitoring indicator ≥ 6,5% * if worsening pre-existing diabetes: * increased capillar or interstitial fasting blood glucose ≥ 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1 * AND postprandial interstitial glucose ≥ + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose ≥ +0,50 g/L
Time frame: Day 14
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