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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03208-49 | Other Identifier | IDRCB |
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The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.
The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place for between 2 and 14 days, or even longer, depending on the system under consideration. Unfortunately, an increase in skin reactions has been observed in diabetic patients using these new technologies, sometimes leading to discontinuation. The number of studies evaluating the cutaneous tolerance of the patches used by these technologies is limited, so the prevalence of these skin intolerances is unknown.
The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes. It will be implemented with the following design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major diabetic subjects having used a system with adhesives | Major diabetic subjects, whatever the etiology of diabetes, using or having used in the last 10 years a system with skin adhesives, i.e. insulin patch pump (e.g. OMNIPOD®, cell Novo®), pump with externalized catheter (e.g. MINIMED 640G®, YpsoPump®) or continuous glucose measurement system (Free Style®, DexCom® sensors, Enlite® sensors). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUTADIAB questionnaire | Other | During a regular diabetes follow-up consultation, the patient is asked to complete the CUTADIAB questionnaire on a tablet, entirely dedicated to the study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of skin intolerance to adhesives in diabetic patients | Percentage of skin intolerance in diabetic patients - all types of diabetes - using or having used in the last 10 years adhesive systems integrated into diabetes medical devices: patch insulin pump, pump with externalized catheter or continuous glucose measurement system. | Single visit at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of skin reactions by adhesive system | Skin intolerance in diabetic patients - all types of diabetes combined - using or having used adhesive systems integrated in diabetes medical devices, depending on the systems used | Single visit at day 0 |
| Consequences of skin reactions |
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Inclusion Criteria:
Exclusion Criteria:
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Major diabetic subjects, whatever the etiology of diabetes, using or having used in the last 10 years a system with skin adhesives, i.e. insulin patch pump (e.g. Omnipod®, cell Novo®), pump with externalized catheter (e.g. Minimed 640G®, Ypsopump®) or continuous glucose measurement system (Free Style®, Dexcom® sensors, Enlite® sensors).
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| Name | Affiliation | Role |
|---|---|---|
| Agnès SOLA GAZAGNES, MD | AP-HP, Cochin Hospital, Department of Diabetology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology | Paris | 75010 | France | |||
| AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36763338 | Result | Diedisheim M, Pecquet C, Julla JB, Carlier A, Potier L, Hartemann A, Jacqueminet S, Vidal-Trecan T, Gautier JF, Dubois Laforgue D, Fagherazzi G, Roussel R, Larger E, Sola-Gazagnes A, Riveline JP. Prevalence and Description of the Skin Reactions Associated with Adhesives in Diabetes Technology Devices in an Adult Population: Results of the CUTADIAB Study. Diabetes Technol Ther. 2023 Apr;25(4):279-286. doi: 10.1089/dia.2022.0513. Epub 2023 Feb 24. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Consequences of skin reactions (continuation / compliance / stopping / stopping then resuming and a delay time before resuming) |
| Single visit at day 0 |
| Percentage of positive responses to the question concerning patient approaches to avoid skin reaction | The patient is asked to answer the question "Do you use or have you used any tips to avoid or treat these skin manifestations" by choosing between the responses provided below (several possible items):
| Single visit at day 0 |
| Percentage of positive responses to the question concerning the delay of appearance of skin manifestation | The patient is asked to answer the question what time passed between the first use of the pump and the first appearance of skin manifestations by choosing between the responses provided below:
| Single visit at day 0 |
| Semiological description of skin lesions | The patient is asked to describe his skin manifestations by choosing between the responses provided below (several possible items):
| Single visit at day 0 |
| Evolution of lesions | The patient is asked to answer the question "How long is the reaction present?" by choosing between the responses provided below :
| Single visit at day 0 |
| Paris |
| 75013 |
| France |
| AP-HP, Cochin Hospital, Department of Diabetology | Paris | 75014 | France |
| AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition | Paris | 75877 | France |