Inflammatory Response to Glucose SensorsTISSUESENSORNCT05755243
Human Subcutaneous Inflammatory Response to Glucose Sensors
An observational study of Inflammatory Response to Glucose Sensors, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Response to Glucose Sensors
- What is being tested?
- glucose sensor
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jun 2022to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighteen people diagnosed with type 1 diabetes and treated with closed-loop systems
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Subcutaneous infLammatory Response to Glucose Sensors: Impact on the Quality of the Measure
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)
Read the 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
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
- Being tested
- glucose sensor
- Keywords
- Enzymatic glucose sensors, foreign body response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose sensorDevice
skin biopsy (punch)
| Study group | Role | What they receive |
|---|---|---|
| Biopsy performed | after 10 days of use, the sensor is removed and the biopsy performed Receives: Device: glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Macrophages sourronding the sensor
Measured: 10 days
MARD (CGM record for 10 days)
median absolute relative difference (BG- Sensor glucose)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start21 Jun 2022
- Primary completion12 Jul 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Response to Glucose SensorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercedes Rigla, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755243
- Sponsor's protocol ID
- PI18/01118
- Acronym
- TISSUESENSOR
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29470128
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Subcutaneous infLammatory Response to Glucose Sensors: Impact on the Quality of the Measure
- ClinicalTrials.gov ID
- NCT05755243
- Acronym / sponsor ID
- TISSUESENSOR / PI18/01118
- Conditions
- Inflammatory Response to Glucose Sensors
- Keywords
- Enzymatic glucose sensors, foreign body response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy performed | – | Device: glucose sensorafter 10 days of use, the sensor is removed and the biopsy performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighteen people diagnosed with type 1 diabetes and treated with closed-loop systems
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucose sensorskin biopsy (punch) | Device | Biopsy performed |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 29470128Rigla 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response to Glucose Sensors, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Macrophages sourronding the sensor (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05755243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.