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

Launched by CAPTEUR PROTECT · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a special adhesive patch, called the COVER PATCH, can help keep continuous glucose monitoring (CGM) sensors securely in place for people with diabetes. CGMs are devices that give real-time readings of blood sugar levels, helping patients manage their diabetes better. Unfortunately, factors like sweating, physical activity, and swimming can cause these sensors to fall off too soon, making it harder to monitor blood sugar and leading to more frequent replacements, which can be costly. The study aims to see if using the COVER PATCH can keep CGMs on longer, improve blood sugar control, and reduce the number of times patients need to change their sensors.

To participate, individuals must be at least 6 years old, diagnosed with type 1 or type 2 diabetes, and currently using a CGM sensor for less than 70% of the time. Participants will continue using their usual CGM and will be randomly assigned to either use the COVER PATCH or not. Throughout the study, participants will fill out questionnaires and report any changes to their sensors. This trial could lead to better solutions for keeping CGM sensors in place, ultimately helping people manage their diabetes more effectively.

Gender

ALL

Eligibility criteria

• 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).