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Interventional Clinical Trial Evaluating COVER PATCH CAPTEUR PROTECT Support Solutions for Continuous Glucose Monitoring Sensors in Patients With Diabetes

RecruitingNAAges 6 Years - anyAllCAPTEUR PROTECT
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In plain words

What the trial is, and whether it could suit you

The aim of this clinical trial is to evaluate whether the COVER PATCH adhesive patch can improve the adhesion of continuous glucose monitors (CGMs). CGMs provide continuous blood sugar readings throughout the day and night, providing valuable data to help individuals manage their diabetes more efficiently. Many people face difficulties in keeping their CGM sensor in place. Factors such as sweat, physical activity, heat, skin creams, and swimming can cause the sensor to fall off prematurely, interrupting glucose monitoring and making it harder to maintain stable blood sugar levels. It has been shown that wearing a CGM sensor for at least 70% of the time is linked to better blood sugar control, measured by lower glycated hemoglobin (HbA1c). HbA1c reflects the average blood sugar over the past 3 months. A lower HbA1c level is associated with better diabetes management. Currently, CGM se

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female * At least 6 years old * Diagnosed with type 1 or type 2 diabetes * Currently using a continuous glucose monitoring (CGM) sensor * CGM sensor usage time \< 70% over the last 4 months * HbA1c ≥ 8% (verified by blood test or capillary test, no older than one month at the time of enrollment) * Patient (or legal representative) owns a smartphone and has internet access (for completing questionnaires) * Patient is covered by a social security scheme * Patient (or legal representative, if applicable) is capable of reading and understanding the study procedure, and is able to give informed consent for participation in the study protocol Exclusion Criteria: * Patient with serious and untreated skin issues in the areas where the device will be applied (e.g., psoriasis, herpetiform dermatitis, skin rash, staphylococcal infection, etc.) * Patient currently participating or having participated in an interventional clinical study within the month prior to enrollment that may impact the study, as determined by the investigator * Patient or their legal representative who is deprived of liberty, under guardianship, or under curatorship. * Pregnant or breastfeeding women, or women of childbearing age without an effective method of contraception, or those who do not agree to continue using contraception throughout the study duration. (Pregnancy will be checked by a urine HCG test for any woman wishing to participate and of childbearing age (under 60 years old).
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What it tests

  • Use of COVER patchs for continuous glucose monitoring sensor
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Where

7 sites
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France
CH Sud Francilien
Corbeil-Essonnes, France
CHU Grenoble Alpes
Grenoble, France
AP-HM Hôpital La Timone - Enfants
Marseille, France
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU Toulouse - Hôpital de Rangueil
Toulouse, France
CHU Guadeloupe
Pointe-à-Pitre, Guadeloupe
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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