COVER PATCH for Continuous Glucose Monitoring in Diabetes
Interventional Clinical Trial Evaluating COVER PATCH CAPTEUR PROTECT Support Solutions for Continuous Glucose Monitoring Sensors in Patients With Diabetes
Recruiting
N/AInterventional Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
194 (estimated)
Sponsor
CAPTEUR PROTECT · Industry
Who this trial is looking for
This trial is looking for people with diabetes who have trouble keeping their glucose monitors in place. Participants will use a special patch to see if it helps the monitor stick better and improve blood sugar control.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 6 years old.
I have been diagnosed with type 1 or type 2 diabetes.
I currently use a continuous glucose monitoring (CGM) sensor.
I have used my CGM sensor less than 70% of the time in the last 4 months.
My HbA1c level is 8% or higher.
I have a smartphone and internet access.
I am covered by a social security scheme.
I can read and understand the study information and give consent.
You may not be able to join if
I have serious untreated skin problems where the patch will go.
I participated in another clinical study in the past month.
I am in a situation where I cannot make decisions for myself.
I am pregnant or breastfeeding, or I do not use birth control if I can get pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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,…
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.
Trial Locations
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Eligibility 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…
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).
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