DiabetesICP-COVERPATCHNCT07018180
Interventional Clinical Trial Evaluating COVER PATCH CAPTEUR PROTECT Support Solutions for Continuous Glucose Monitoring Sensors in Patients With Diabetes
A study testing Use of COVER patchs for continuous glucose monitoring sensor in people with Diabetes, run by CAPTEUR PROTECT at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Use of COVER patchs for continuous glucose monitoring sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Dec 2025to 5 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
France6 sites, 6 recruiting
- Not yet recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69677
Kévin PERGE, MD, +334 72 11 88 90, kevin.perge@chu-lyon.fr
Kévin PERGE
- Recruiting
CH Sud Francilien
Corbeil-Essonnes, 91100
Alfred PENFORNIS, MD, +331 61 69 82 77, alfred.penfornis@chsf.fr
Alfred PENFORNIS
- Not yet recruiting
CHU Grenoble Alpes
Grenoble, 38043
Pierre-Yves BENHAMOU, MD, +334 76 76 55 09, pybenhamou@chu-grenoble.fr
Pierre-Yves BENHAMOU
- Not yet recruiting
AP-HM Hôpital La Timone - Enfants
Marseille, 13385
Rachel REYNAUD, MD, +334 91 38 83 84, rachel.reynaud@ap-hm.fr
Rachel REYNAUD
- Not yet recruiting
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Eric RENARD, MD, +334 67 33 83 82, e-renard@chu-montpellier.fr
Eric RENARD
- Not yet recruiting
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31400
Hélène HANAIRE, MD, +335 61 32 30 18, hanaire.h@chu-toulouse.fr
Hélène HANAIRE
Guadeloupe1 site, 1 recruiting
- Not yet recruiting
CHU Guadeloupe
Pointe-à-Pitre, 97110
Fritz-Line VELAYOUDOM, MD, +335 90 89 13 09, fritz-line.velayoudom@univ-antilles.fr
Fritz-Line VELAYOUDOM
About this study
Official title: Interventional Study Evaluating the Use of COVER PATCH CAPTEUR PROTECT Support Solutions in Patients Living With Diabetes: a Prospective, Randomized, Controlled, Multicenter Study
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.
Read more
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.
Read the detailed description
The main objective of the study is to evaluate the effectiveness of COVER PATCH CAPTEUR PROTECT solutions for glucose sensors, in terms of improving glycemic control in patients with poorly controlled diabetes and suboptimal sensor wear time, compared to management without the COVER PATCH.
This is an interventional, prospective, randomized, controlled, multicenter clinical trial comparing the HbA1c levels of patients using COVER PATCH CAPTEUR PROTECT solutions for glucose sensors versus standard care.
The use of COVER PATCH CAPTEUR PROTECT solutions could result in a 0.3 percentage point improvement in HbA1c in diabetic patients initially having an HbA1c ≥ 8% and a glycemic sensor wear time of < 70%.
The device under study is the COVER PATCH solution by CAPTEUR PROTECT. This patch is a Class I, non-sterile, single-use device. COVER patches are intended for use in association with continuous glucose monitoring devices for patients living with diabetes.
COVER patches are compatible with a wide range of continuous glucose monitoring (CGM) devices available on the market. Several versions of the patches are available depending on the type of sensor (Freestyle 2 or 3, Dexcom G6/One or G7/One+, Guardian Sensor 4 or Simplera).
In this study, participants use their regular continuous glucose monitor (CGM), either with or without the adhesive patch being evaluated. Upon enrollment, retrospective data from the past 4 months are collected for analysis.
At the start of the study, participants complete the following questionnaires:
- Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs)
- Diabetes Distress Scale (DDS) The adult, adolescent, or parent version is be provided depending on the participant's age.
Throughout the study, participants use an electronic tool (ePRO) to record each sensor change and indicate the reason for the replacement. Participants can also report any adverse events and device deficiency.
After 4 months, a follow-up visit takes place. Data from the previous 4 months are collected for analysis. Participants complete the same questionnaires again, as well as additional ones:
- Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc)
- Physical activity questionnaire
- Satisfaction questionnaire regarding cover patch use The adult, adolescent, or parent version is be provided depending on the participant's age.
The study duration per patient is 4 months.
- Conditions
- Diabetes
- Being tested
- Use of COVER patchs for continuous glucose monitoring sensor
- Keywords
- Diabetes, Continuous glucose monitoring, Adhesive patch, Cover patch, Poorly controlled
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of COVER patchs for continuous glucose monitoring sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| COVER PATCH | Experimental | Participants use their usual continuous glucose monitoring (CGM) sensor with the COVER PATCH adhesive patch during the study. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Comparison of the average sensor wear time, in days, over 4 months
Measured: 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.
Measured: 4 months
Comparison of sensors' number used over 4 months
Measured: 4 months
Comparison of number change events for sensors, categorized by reason for change (detachment, loss of connection, etc.) at 4 months
Measured: 4 months
Comparison of change in scores of the Diabetes Treatment Satisfaction Questionnaire status at baseline (DTSQs) and at 4 months (DTSQs and DTSQc)
Adolescents (aged 12 to 17) will complete the age-appropriate version, the DTSQ-Teen. Parents of children aged 11 or younger will complete the parent version of the DTSQ (Parent-DTSQ)
The DTSQ status (DTSQs) items are scored on a scale from 6 to 0 and DTSQ change (DTSQc) items are on a scale from 3 to -3.
Higher is the score, the more the participant is satisfied (for DTSQs and DTSQc).
DTSQs : The score ranges from 0 to 48 DTSQ parent : The score ranges from 0 to 84 DTSQ teen : The score ranges from 0 to 72 DTSQc Teen : The score ranges from -36 to 36 DTSQc Parent : The score ranges from -36 to 36 DTSQc : The score ranges from -24 to 24
Measured: 4 months
Comparison of change in scores of the Diabetes Distress Scale (DDS) or the Parent Diabetes Distress Scale (Parent-DDS) at baseline and at 4 months
The DDS items are scored on a scale from 1 to 6. The score ranges from 1 to 6 (total score divided by the number of items) Higher is the score, the more living with diabetes is a burden for participant.
The Parent-DDS items are scored on a scale from 1 to 5. The score ranges from 1 to 5 (total score divided by the number of items) Higher is the score, the more caring a children with diabetes is difficult for parents.
Measured: 4 months
Assessment of the COVER PATCH CAPTEUR PROTECT satisfaction questionnaire, completed at 4 months
Satisfaction's evaluation : only for the interventional group, at 4 months Global satisfaction item with a scale from 1 to 5 Higher is the score, the more satisfied is the participant
Measured: 4 months
Comparison of the percentage (%) of time spent in closed-loop mode
Only for participants in closed-loop
Measured: 4 months
Comparison of the estimated HbA1c level (%) (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage (or average duration) of data captured (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage of time spent in the glucose range < 54 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage of time spent in the glucose range 54-69 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage of time spent in the glucose range 181-250 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage of time spent in the glucose range > 250 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the percentage of time spent in the target glucose range 70-140 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the average glucose level (mg/dL) (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of the daily glycemic coefficient of variation (collected from CGM plateforms, between baseline and 4 months)
Measured: 4 months
Comparison of adverse events' number, serious adverse events, adverse effects related to support solutions, and unexpected serious adverse effects related to support solutions occurring during the follow-up period
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start5 Dec 2025
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAPTEUR PROTECT
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018180
- Sponsor's protocol ID
- 2024-A01872-45
- Acronym
- ICP-COVERPATCH
- Status last verified
- Dec 2025
- First submitted
- 22 May 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study Evaluating the Use of COVER PATCH CAPTEUR PROTECT Support Solutions in Patients Living With Diabetes: a Prospective, Randomized, Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT07018180
- Acronym / sponsor ID
- ICP-COVERPATCH / 2024-A01872-45
- Conditions
- Diabetes
- Keywords
- Diabetes, Continuous glucose monitoring, Adhesive patch, Cover patch, Poorly controlled
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- CAPTEUR PROTECTIndustry (pharma, biotech, devices)
- Collaborators
- Icadom
- Study start
- 5 Dec 2025 (actual)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of the study is to evaluate the effectiveness of COVER PATCH CAPTEUR PROTECT solutions for glucose sensors, in terms of improving glycemic control in patients with poorly controlled diabetes and suboptimal sensor wear time, compared to management without the COVER PATCH.
This is an interventional, prospective, randomized, controlled, multicenter clinical trial comparing the HbA1c levels of patients using COVER PATCH CAPTEUR PROTECT solutions for glucose sensors versus standard care.
The use of COVER PATCH CAPTEUR PROTECT solutions could result in a 0.3 percentage point improvement in HbA1c in diabetic patients initially having an HbA1c ≥ 8% and a glycemic sensor wear time of < 70%.
The device under study is the COVER PATCH solution by CAPTEUR PROTECT. This patch is a Class I, non-sterile, single-use device. COVER patches are intended for use in association with continuous glucose monitoring devices for patients living with diabetes.
COVER patches are compatible with a wide range of continuous glucose monitoring (CGM) devices available on the market. Several versions of the patches are available depending on the type of sensor (Freestyle 2 or 3, Dexcom G6/One or G7/One+, Guardian Sensor 4 or Simplera).
In this study, participants use their regular continuous glucose monitor (CGM), either with or without the adhesive patch being evaluated. Upon enrollment, retrospective data from the past 4 months are collected for analysis.
At the start of the study, participants complete the following questionnaires:
- Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs)
- Diabetes Distress Scale (DDS) The adult, adolescent, or parent version is be provided depending on the participant's age.
Throughout the study, participants use an electronic tool (ePRO) to record each sensor change and indicate the reason for the replacement. Participants can also report any adverse events and device deficiency.
After 4 months, a follow-up visit takes place. Data from the previous 4 months are collected for analysis. Participants complete the same questionnaires again, as well as additional ones:
- Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc)
- Physical activity questionnaire
- Satisfaction questionnaire regarding cover patch use The adult, adolescent, or parent version is be provided depending on the participant's age.
The study duration per patient is 4 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVER PATCH | Experimental | Device: Use of COVER patchs for continuous glucose monitoring sensorParticipants use their usual continuous glucose monitoring (CGM) sensor with the COVER PATCH adhesive patch during the study. |
| 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) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of COVER patchs for continuous glucose monitoring sensorThe 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. | Device | COVER PATCH |
Primary outcome
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
Time frame: 4 months
19 secondary outcomes
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
Time frame: 4 months
Comparison of the average sensor wear time, in days, over 4 months
Time frame: 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.
Time frame: 4 months
Comparison of sensors' number used over 4 months
Time frame: 4 months
Comparison of number change events for sensors, categorized by reason for change (detachment, loss of connection, etc.) at 4 months
Time frame: 4 months
Comparison of change in scores of the Diabetes Treatment Satisfaction Questionnaire status at baseline (DTSQs) and at 4 months (DTSQs and DTSQc)
Time frame: 4 months
Comparison of change in scores of the Diabetes Distress Scale (DDS) or the Parent Diabetes Distress Scale (Parent-DDS) at baseline and at 4 months
Time frame: 4 months
Assessment of the COVER PATCH CAPTEUR PROTECT satisfaction questionnaire, completed at 4 months
Time frame: 4 months
Comparison of the percentage (%) of time spent in closed-loop mode
Time frame: 4 months
Comparison of the estimated HbA1c level (%) (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage (or average duration) of data captured (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage of time spent in the glucose range < 54 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage of time spent in the glucose range 54-69 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage of time spent in the glucose range 181-250 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage of time spent in the glucose range > 250 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the percentage of time spent in the target glucose range 70-140 mg/dL (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the average glucose level (mg/dL) (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of the daily glycemic coefficient of variation (collected from CGM plateforms, between baseline and 4 months)
Time frame: 4 months
Comparison of adverse events' number, serious adverse events, adverse effects related to support solutions, and unexpected serious adverse effects related to support solutions occurring during the follow-up period
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of COVER patchs for continuous glucose monitoring sensor in people with Diabetes, run by CAPTEUR PROTECT at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie GUILLAUME (+337 57 10 56 82, lguillaume@capteurprotect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.