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

NCT07018180 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

DEVICE

Use of COVER patchs for continuous glucose monitoring sensor

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.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • CAPTEUR PROTECT

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Completion
2027-01-05

Countries

  • France
  • Guadeloupe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018180 on ClinicalTrials.gov