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

NCT07018180 | Recruiting

• 1 other identifier: 2024-A01872-45
• Study Type: interventional
• Target: 194
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Diabetes

Keywords

Diabetes; Continuous glucose monitoring; Adhesive patch; Cover patch; Poorly controlled

Outcome Measures

Primary Outcomes (1)

• Comparison of the evolution of blood HbA1c, expressed in percentage points between enrollment and 4 months, in patients living with diabetes, with or without the COVER PATCH CAPTEUR PROTECT solution

  4 months

Secondary Outcomes (19)

• Comparison of the average sensor wear time over 4 months, reported in percentage points relative to the duration of use claimed by the sensor manufacturers

  4 months

• Comparison of the average sensor wear time, in days, over 4 months

  4 months

• Comparison of the percentage (%) of patients for whom the sensor wear duration reached the maximum duration claimed by the manufacturer during the 4-month study period.

  4 months

• Comparison of sensors' number used over 4 months

  4 months

• Comparison of number change events for sensors, categorized by reason for change (detachment, loss of connection, etc.) at 4 months

  4 months

Study Arms (2)

COVER PATCH

EXPERIMENTAL

Participants use their usual continuous glucose monitoring (CGM) sensor with the COVER PATCH adhesive patch during the study.

Device: Use of COVER patchs for continuous glucose monitoring sensor

Standard of care

NO INTERVENTION

Participants use their usual continuous glucose monitoring (CGM) sensor without the COVER PATCH adhesive patch during the study (standard of care)

Interventions

Use of COVER patchs for continuous glucose monitoring sensor DEVICE

The intervention consists of wearing a patch over the continuous glucose monitoring (CGM) sensor typically used by the participant. The COVER patch is compatible with a wide range of CGM devices on the market, including Freestyle 2 or 3, Dexcom G6/One or G7/One+, and Guardian Sensor 4 or Simplera. At each sensor change, the participant is required to apply a new COVER PATCH over the CGM sensor. This is done throughout the entire duration of their participation in the study, which lasts for 4 months.

COVER PATCH

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icadom: collaborator
• CAPTEUR PROTECT: lead

Study Sites (7)

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, 69677, France

NOT YET RECRUITING

CH Sud Francilien

Corbeil-Essonnes, 91100, France

RECRUITING

CHU Grenoble Alpes

Grenoble, 38043, France

NOT YET RECRUITING

AP-HM Hôpital La Timone - Enfants

Marseille, 13385, France

NOT YET RECRUITING

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

NOT YET RECRUITING

CHU Toulouse - Hôpital de Rangueil

Toulouse, 31400, France

NOT YET RECRUITING

CHU Guadeloupe

Pointe-à-Pitre, 97110, Guadeloupe

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Laurie GUILLAUME

CONTACT

+337 57 10 56 82; lguillaume@capteurprotect.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 12, 2025
• Study Start: December 5, 2025
• Study Completion (Estimated): January 5, 2027
• Last Updated: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); GU (1)