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Interventional Study Evaluating the Use of COVER PATCH CAPTEUR PROTECT Support Solutions in Patients Living With Diabetes: a Prospective, Randomized, Controlled, Multicenter Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
NOT_YET_RECRUITING
Bron
CH Sud Francilien
RECRUITING
Corbeil-essonnes
CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
AP-HM Hôpital La Timone - Enfants
NOT_YET_RECRUITING
Marseille
CHRU de Montpellier - Hôpital Lapeyronie
NOT_YET_RECRUITING
Montpellier
CHU Toulouse - Hôpital de Rangueil
NOT_YET_RECRUITING
Toulouse
Guadeloupe
CHU Guadeloupe
NOT_YET_RECRUITING
Pointe-à-pitre
Contact Information
Primary
Laurie GUILLAUME
lguillaume@capteurprotect.com
+337 57 10 56 82
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2027-01-05
Participants
Target number of participants: 194
Treatments
Experimental: COVER PATCH
Participants use their usual continuous glucose monitoring (CGM) sensor with the COVER PATCH adhesive patch during the study.
No_intervention: Standard of care
Participants use their usual continuous glucose monitoring (CGM) sensor without the COVER PATCH adhesive patch during the study (standard of care)
Related Therapeutic Areas
Sponsors
Collaborators: Icadom
Leads: CAPTEUR PROTECT

This content was sourced from clinicaltrials.gov