Interventional Clinical Trial Evaluating COVER PATCH CAPTEUR PROTECT Support Solutions for Continuous Glucose Monitoring Sensors in Patients With Diabetes (NCT07018180)
🩺 Plain-English Summary (8th-Grade Level)
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 sensors are designed for one-time use and need to be replaced every 7 to 15 days. However, when sensors fall off prematurely, they need to be replaced more frequently, leading to higher costs for patients. This can exceed what is covered by insurance. Some patients use non-approved solutions, like extra adhesive tapes, to keep their sensors in place, but these methods may not be effective. This clinical trial aims to answer the following questions: * Does the adhesive patch help keep the CGM sensor in place for the full recommended duration? * Does better sensor adhesion lead to improved blood sugar control and lower HbA1c? * Does the patch help reduce the frequency of premature sensor replacements? To take part in this study, participants must be at least 6 years old and have type 1 or type 2 diabetes. Participants continue using their usual CGM during the study and are randomly assigned to either use the adhesive patch (COVER PATCH) or not. Participants and/or their parents (depending on the participant's age) complete questionnaires at the start of the study, and again at the end of the study at 4 months. Throughout the 4-month period, they also use an electronic tool (ePRO) to record each CGM sensor change and the reason for replacement. This study may help improve how well glucose sensors stay in place, reduce the need to change them too often, and make it easier to manage blood sugar. It also aims to fulfill a medical need that is currently not adequately covered.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (5 items).
Location: Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron,
- CH Sud Francilien — Corbeil-Essonnes,
- CHU Grenoble Alpes — Grenoble,
- AP-HM Hôpital La Timone - Enfants — Marseille,
- CHRU de Montpellier - Hôpital Lapeyronie — Montpellier,
- CHU Toulouse - Hôpital de Rangueil — Toulouse,
- CHU Guadeloupe — Pointe-à-Pitre,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.