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The aim of the study is to describe the inflammatory response to enzimatic glucose sensors after 10 days of use and to evaluate the relationship between the magnitude of the FBR (foreign body response) with the accuracy of the sensor (MARD)
Eighteen Type 1 DM patients are going to be included. Primary Objectives
Secondary Objectives
To describe the histology of tissue response. This description will include:
Each patient will have 1 glucose sensor inserted in the non-dominant arm. During the useful life of the sensor (10), a minimum of 4 capillary blood glucose determinations/day will be performed The sensor has a length of 8 mm and a diameter of 0.4 mm. All the necessary material will be provided, including a control diary to help the patient remember to carry out the self-control and set its time distribution.
On the last day of sensor use, it will be removed and a 4-mm punch skin biopsy will be performed 5 minutes later.
Tissue samples will be fixed in 4% formaldehyde solution, paraffin blocks made and sectioned. The resulting samples will be stained Semiquantitative determination of lymphocytes, neutrophils, mast cells, macrophages will be performed; fibrin, fibrosis, vascular proliferation and karyorrhexis
In all cases, a quantitative immunohistochemical study will be performed with x40 field counting with photographs and grid (Dako omnis with envision system) for:
Macrophages
The monitor-glucometer will be recovered for download and study of the record. The interstitial glucose - blood pairs will be made with those recorded but not used for callibration.
Glucose sensor values and insulin doses will be recover from tha medical application
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy performed | after 10 days of use, the sensor is removed and the biopsy performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose sensor | Device | skin biopsy (punch) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Macrophages sourronding the sensor | 10 days | |
| MARD (CGM record for 10 days) | median absolute relative difference (BG- Sensor glucose) | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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Eighteen people diagnosed with type 1 diabetes and treated with closed-loop systems
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29470128 | Background | Rigla M, Pons B, Rebasa P, Luna A, Pozo FJ, Caixas A, Villaplana M, Subias D, Bella MR, Combalia N. Human Subcutaneous Tissue Response to Glucose Sensors: Macrophages Accumulation Impact on Sensor Accuracy. Diabetes Technol Ther. 2018 Apr;20(4):296-302. doi: 10.1089/dia.2017.0321. Epub 2018 Feb 22. |
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S.c. tissue biopsy