NCT05755243

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

February 23, 2023

Last Update Submit

September 27, 2023

Conditions

Inflammatory Response to Glucose Sensors

Keywords

Enzymatic glucose sensors, foreign body response

Outcome Measures

Primary Outcomes (2)

  • Number of Macrophages sourronding the sensor

    10 days

  • MARD (CGM record for 10 days)

    median absolute relative difference (BG- Sensor glucose)

    10 days

Study Arms (1)

Biopsy performed

after 10 days of use, the sensor is removed and the biopsy performed

Device: glucose sensor

Interventions

glucose sensorDEVICE

skin biopsy (punch)

Biopsy performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eighteen people diagnosed with type 1 diabetes and treated with closed-loop systems

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29470128BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

S.c. tissue biopsy

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

June 21, 2022

Primary Completion

July 12, 2023

Study Completion

September 20, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

ES(1)