NCT05755243CompletedNot Applicable
Human Subcutaneous infLammatory Response to Glucose Sensors: Impact on the Quality of the Measure
Corporacion Parc Tauli1 site in 1 country24 target enrollmentStarted: June 21, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Macrophages sourronding the sensor
Study Overview
Brief 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
- To define the intra-individual and inter-individual variability of the macrophage count around the sensor
- 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:
- HE stain: cell types, arrangement, vascular structures, signs of hemorrhage-clot. Giemsa stain: mast cells. Masson's trichrome stain: str. vascular.
- Immunohistochemistry: Vascular assessment, characterization of macrophages
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes of more than 6 months duration, confirmed by positivity for Ab antiGAD 65
- •Be a regular user of a continuous glucose monitoring system
- •To Understand the proposed protocol and acceptance of participation.
Exclusion Criteria
- •Treatment with drugs that could potentially modify the inflammatory response during the 10 days prior to surgery (non-steroidal anti-inflammatory drugs or corticosteroids, antioxidants or platelet antiaggregants).
Outcomes
Primary Outcomes
Number of Macrophages sourronding the sensor
Time Frame: 10 days
MARD (CGM record for 10 days)
Time Frame: 10 days
median absolute relative difference (BG- Sensor glucose)
Secondary Outcomes
No secondary outcomes reported
Investigators
Mercedes Rigla
Director of Department
Corporacion Parc Tauli
Study Sites (1)
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