NCT05755243

Human Subcutaneous Inflammatory Response to Glucose Sensors

Human Subcutaneous infLammatory Response to Glucose Sensors: Impact on the Quality of the Measure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Eighteen Type 1 DM patients are going to be included. Primary Objectives 1. To define the intra-individual and inter-individual variability of the macrophage count around the sensor 2. To assess whether there is a relationship between the number of macrophages, fibrosis and MARD of the MCG registry. Secondary Objectives To describe the histology of tissue response. This description will include: 1. HE stain: cell types, arrangement, vascular structures, signs of hemorrhage-clot. Giemsa stain: mast cells. Masson's trichrome stain: str. vascular. 2. Immunohistochemistry: Vascular assessment, characterization of macrophages 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

Conditions

• Inflammatory Response to Glucose Sensors

Interventions

Type	Name	Description
DEVICE	glucose sensor	skin biopsy (punch)

Timeline

• Start date: 2022-06-21
• Primary completion: 2023-07-12
• Completion: 2023-09-20
• First posted: 2023-03-06
• Last updated: 2023-09-28

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study