COVER PATCH CAPTEUR PROTECT to help keep CGM sensors attached
Interventional Study Evaluating the Use of COVER PATCH CAPTEUR PROTECT Support Solutions in Patients Living With Diabetes: a Prospective, Randomized, Controlled, Multicenter Study
NA · CAPTEUR PROTECT · NCT07018180
This trial will test whether using the COVER PATCH adhesive helps people with diabetes who wear continuous glucose monitors keep their sensors on longer and lower their average blood sugar (HbA1c).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | CAPTEUR PROTECT (industry) |
| Locations | 7 sites (Bron and 6 other locations) |
| Trial ID | NCT07018180 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled, multicenter trial comparing usual care versus use of the COVER PATCH CAPTEUR PROTECT adhesive for continuous glucose monitoring (CGM) sensors. Participants are people with type 1 or type 2 diabetes, HbA1c ≥ 8%, and documented CGM wear time under 70% over the prior four months. After collecting retrospective baseline data, enrolled patients are randomized to use their regular CGM either with the COVER PATCH or without it, and outcomes such as sensor wear time and HbA1c are tracked. The device is a Class I, single-use adhesive patch compatible with multiple commercial CGM sensors.
Who should consider this trial
Good fit: Ideal candidates are people aged 6 or older with type 1 or type 2 diabetes who currently use a CGM, have less than 70% sensor wear time, and have an HbA1c of 8% or higher.
Not a fit: Patients with good CGM adherence (≥70% wear time), HbA1c below 8%, or active untreated skin problems at the sensor site are unlikely to benefit from the patch.
Why it matters
Potential benefit: If successful, the patch could increase CGM wear time and produce an average HbA1c improvement of about 0.3 percentage points in poorly controlled patients.
How similar studies have performed: Adhesive patches for CGMs are commonly used and observational data show higher wear time is linked to better HbA1c, but randomized data specific to this COVER PATCH device are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bron and 6 other locations
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron, France (NOT_YET_RECRUITING)
- CH Sud Francilien — Corbeil-Essonnes, France (RECRUITING)
- CHU Grenoble Alpes — Grenoble, France (NOT_YET_RECRUITING)
- AP-HM Hôpital La Timone - Enfants — Marseille, France (NOT_YET_RECRUITING)
- CHRU de Montpellier - Hôpital Lapeyronie — Montpellier, France (NOT_YET_RECRUITING)
- CHU Toulouse - Hôpital de Rangueil — Toulouse, France (NOT_YET_RECRUITING)
- CHU Guadeloupe — Pointe-à-Pitre, Guadeloupe (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Laurie GUILLAUME
- Email: lguillaume@capteurprotect.com
- Phone: +337 57 10 56 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes, Continuous glucose monitoring, Adhesive patch, Cover patch, Poorly controlled