An interventional study of Use of COVER patchs for continuous glucose monitoring sensor in Diabetes, sponsored by CAPTEUR PROTECT. Recruiting at 7 sites in 2 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by CAPTEUR PROTECT · Not applicable, Interventional, and Supportive care
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:
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.
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:
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:
The study duration per patient is 4 months.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 194 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with CAPTEUR PROTECT as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants use their usual continuous glucose monitoring (CGM) sensor without the COVER PATCH adhesive patch during the study (standard of care)
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.
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
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)
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
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
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.
Time frame: 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
Time frame: 4 months
Comparison of the percentage (%) of time spent in closed-loop mode
Only for participants in closed-loop
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.