CompletedNot Applicable

Human Subcutaneous Inflammatory Response to Glucose Sensors

Spain24 participantsStarted 2022-06-21

Plain-language 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)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Type 1 diabetes of more than 6 months duration, confirmed by positivity for Ab antiGAD 65 2. Be a regular user of a continuous glucose monitoring system 2. 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).

What they're measuring

Number of Macrophages sourronding the sensor

Timeframe: 10 days

MARD (CGM record for 10 days)

Timeframe: 10 days

Trial details

NCT IDNCT05755243

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-12

View on ClinicalTrials.gov More Inflammatory Response to Glucose Sensors trials