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Clinical Trial NCT05107388 (AAREN) for Breast Cancer, Diabetes is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer (AAREN) 40
Clinical Trial NCT05107388 (AAREN) is an interventional study for Breast Cancer, Diabetes that is unknown status. It started on December 1, 2021 with plans to enroll 40 participants. Led by Centre Hospitalier Universitaire de Besancon, it is expected to complete by March 1, 2024. The latest data from ClinicalTrials.gov was last updated on November 4, 2021.
Brief Summary
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
Detailed Description
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.
Official Title
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
Conditions
Breast CancerDiabetesOther Study IDs
- AAREN
- 2021/609
NCT ID Number
Start Date (Actual)
2021-12
Last Update Posted
2021-11-04
Completion Date (Estimated)
2024-03
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Unknown status
Keywords
Breast Cancer, Alpelisib, hyperglycemia
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalContinuous interstitial glucose measurements Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro | FreeStyle Libre Pro Measurements of interstitial glucose variations with FreeStyle Libre Pro |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Day 14 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Women suffering breast cancer and eligible to treatment with Alpelisib
- Age ≥18 years
- Menopausal women (for at least 24 months)
- Informed Consent Form signed
- Men
- Pregnant ou child-bearing potential women
Centre Hospitalier Universitaire de BesanconStudy Central Contact
Contact: Fatimata SARR SALL, PhD, 033381219449, [email protected]
1 Study Locations in 1 Countries
CHU de Besançon, Besançon, 25000, France
Fatimata SARR SALL, PhD, Contact, [email protected]