Observational Study of the Use of DBLG1 System in Real Life (SP12)

May 6, 2024 updated by: Diabeloop

This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician.

Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed to address the specific requirements from National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) and to complete data obtained up to now, with a larger cohort and in real life settings.

In order to increase variability in the profiles of patients included and to be as representative as possible of all eligible patients, 20 centers will participate in the study, both private and public, with a mix of university and regional centers and 348 patients will be included consecutively.

The inclusion period lasts 6 months and each patient will be included in the study for a period of 2 weeks of run-in and 1 year of treatment. An inclusion period of 6 months is enough according to investigation site data and estimation of inclusion over 6 months (detailed in part Healthcare professional and investigation centers recruitment).

This study is observational. Patients included follow their usual medical care and will only be asked for the specific need of the study to answer two questionnaires (at the beginning and at the end of the study) and give their HbA1c results performed in their current medical follow-up. As it is a post-registration study, medical devices are provided to patients on medical prescription by healthcare providers, which have signed a distribution agreement with and have been trained by Diabeloop. Patients have their system for 4 a maximum of 4 years (life duration of the medical device (DBLG1 System)).

Patients follow-up visits are not mandatory and no frequency is imposed. Investigators, according to their habits, have follow-up visits corresponding to what they usually propose to patients having a new treatment.

During the whole study and apart from scheduled visits (inclusion, beginning of run-in, beginning of treatment , enf of study), each patient may contact his/her clinician investigator in case of issue he/she judges as serious, for questions, etc. In that case, the clinician may program a visit with the patient and deal with adverse events. Phone calls are recorded in Case Report Form (CRF), as well as on-site visits.

Note: with Yourloops; investigators may follow the state of their patients, regarding the time in range, mean glycemia value etc. Based on this, they may require a visit at their convenience with the patient in order to change parameters of the system, discuss adverse events, etc.

Objectives are the following To evaluate improvement in blood glucose control with use of DBLG1 System after one year in real life.

To evaluate details of glycemic control improvement, safety and adverse events due to the DBLG1 System, evolution of quality of life after one year in real life and healthcare professional support.

Study endpoints Improvement of the time in glycemic range 70 - 180 mg/dL, in percentage, on 24hours and nighttime.

HbA1c Mean CGM glucose - on 24hours and nighttime Time in 70 - 140 mg/dL range on 24hours and nighttime only Time in hypoglycemia (under 70 mg/dL, 60 mg/dL and 50 mg/dL) - on 24hours and nighttime Time in hyperglycemia (above 180 mg/dL, 250 mg/dL and 300 mg/dL) - on 24hours and nighttime Percentage of time using activated loop mode vs. deactivated loop mode Standard Deviation (SD) and Coefficient of variation (CV) of Continuous Glucose Monitoring (CGM) values on 24hours and nighttime Number and type of adverse events Overall and diabetic-specific quality of life Quantification of the healthcare professional support required

An descriptive interim analysis will be made on the first 100 enrolled patients after 6 months of use of the DBLG1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bobigny, France, 93000
        • Not yet recruiting
        • Hôpital Avicenne APHP
        • Contact:
        • Principal Investigator:
          • Emmanuel Cosson, Pr
        • Sub-Investigator:
          • Sopio Tatulashvili, Dr
        • Sub-Investigator:
          • Hélène Bihan, Dr
        • Sub-Investigator:
          • Meriem Sal, Dr
      • Brest, France, 29200
        • Not yet recruiting
        • Hopital De La Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Emmanuel Cosson, Dr
        • Sub-Investigator:
          • Nathalie Roudaut, Dr
        • Sub-Investigator:
          • Genevieve Crouzeix, Dr
      • Caen, France, 14000
        • Recruiting
        • CHU CAEN
        • Contact:
        • Principal Investigator:
          • Yves Reznik, Pr
        • Sub-Investigator:
          • Michael Joubert, Dr
        • Sub-Investigator:
          • Anne Rod, Dr
        • Sub-Investigator:
          • Julia Morera, Dr
        • Sub-Investigator:
          • Bleuenn Dreves, Dr
      • Corbeil-Essonnes, France, 91100
        • Not yet recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
        • Principal Investigator:
          • Alfred Penfornis, Pr
        • Sub-Investigator:
          • Sylvia France, Dr
        • Sub-Investigator:
          • Coralie Amadou, Dr
        • Sub-Investigator:
          • Catherine Petit, Dr
      • Dijon, France, 21079
        • Recruiting
        • CHU Bocage Central
        • Contact:
        • Principal Investigator:
          • Sabine Baillot-Rudoni, Dr
        • Sub-Investigator:
          • Bruno Verges, Dr
        • Sub-Investigator:
          • Jean Michel Petit, Dr
        • Sub-Investigator:
          • Benjamin Bouillet, Dr
        • Sub-Investigator:
          • Elodie Crevisy, Dr
        • Sub-Investigator:
          • Alexia Rouland, Dr
        • Sub-Investigator:
          • Coralie Fourmont, Dr
      • Eaubonne, France, 95600
        • Not yet recruiting
        • Hôpital Simone Veil
        • Contact:
        • Principal Investigator:
          • Karim Lachgar, Dr
        • Sub-Investigator:
          • Amina Mankai, Dr
        • Sub-Investigator:
          • Sylvie Casteras, Dr
        • Sub-Investigator:
          • Nasrine Achour, Dr
        • Sub-Investigator:
          • Anissa Mouffok, Dr
        • Sub-Investigator:
          • Diane-Cécile Gauthier, Dr
      • Grenoble, France, 38000
        • Recruiting
        • CHU Grenoble
        • Contact:
        • Sub-Investigator:
          • Pierre-Yves Benhamou, Pr
        • Principal Investigator:
          • Sandrine Lablanche, Dr
        • Sub-Investigator:
          • Isabelle Debaty, Dr
        • Sub-Investigator:
          • Manon Jalbert, Dr
        • Sub-Investigator:
          • Johanna Delagenière, Dr
        • Sub-Investigator:
          • Cécile Bétry, Fr
      • La Rochelle, France, 17019
        • Recruiting
        • Groupe Hospitalier La Rochelle - Re - Aunis
        • Contact:
        • Sub-Investigator:
          • Frédérique Duengler, Dr
        • Principal Investigator:
          • Didier Gouet, Dr
        • Sub-Investigator:
          • Sophie Gaulier, Dr
        • Sub-Investigator:
          • Claire Cordroc'h, Dr
        • Sub-Investigator:
          • Camille Bouche, Dr
        • Sub-Investigator:
          • Céline Olivier, Dr
      • Lille, France, 59037
        • Not yet recruiting
        • Chu Lille
        • Contact:
        • Principal Investigator:
          • Anne Vambergue, Pr
        • Sub-Investigator:
          • Florence Baudoux, Dr
        • Sub-Investigator:
          • Wassila Karrouz-Ribeiro, Dr
        • Sub-Investigator:
          • Madleen Lemaitre, Dr
        • Sub-Investigator:
          • Kristelle Le Mapihan, Dr
        • Sub-Investigator:
          • Emilie Merlen, Dr
      • Lyon, France, 69008
        • Not yet recruiting
        • Diab-e-Care
        • Contact:
        • Principal Investigator:
          • Charles Thivolet, Pr
        • Sub-Investigator:
          • Mélanie Gaudillere, Dr
        • Sub-Investigator:
          • Béatrice Mestre, Dr
        • Sub-Investigator:
          • Sylvie Villar-Fimbel, Dr
      • Marseille, France, 13003
      • Marseille, France, 13385
        • Not yet recruiting
        • Hôpital la conception, pole ENDO
        • Contact:
        • Principal Investigator:
          • Pauline Schaepelynck, Dr
      • Nantes, France, 44093
        • Recruiting
        • Hopital Nord Laennec
        • Contact:
        • Principal Investigator:
          • Lucy Chaillous, Dr
        • Sub-Investigator:
          • Emeric Scharbarg, Dr
        • Sub-Investigator:
          • Sarra Smati-Grangeon, Dr
        • Sub-Investigator:
          • Pierre Morcel, Dr
      • Paris, France, 75010
        • Not yet recruiting
        • Lariboisière - Fernand Widal APHP
        • Contact:
        • Principal Investigator:
          • Jean Pierre Riveline, Pr
        • Sub-Investigator:
          • Tiphaine Vidal-Trecan, Dr
        • Sub-Investigator:
          • Jean-Baptiste Julla, Dr
      • Paris, France, 75018
        • Not yet recruiting
        • Hôpital Bichet Claude Bernard - APHP
        • Contact:
        • Principal Investigator:
          • Louis Potier, Dr
        • Sub-Investigator:
          • Florence Travert, Dr
        • Sub-Investigator:
          • Aurélie Carlier, Dr
      • Pau, France, 64000
        • Not yet recruiting
        • Clinique Princess
        • Contact:
        • Principal Investigator:
          • Anne Violante, Dr
        • Sub-Investigator:
          • Marie-Pierre Etchandy, Dr
        • Sub-Investigator:
          • Sandrine Menon, Dr
        • Sub-Investigator:
          • Elodie Malville-Cabal, Dr
        • Sub-Investigator:
          • Christian Bonnin, Dr
      • Reims, France, 51100
        • Recruiting
        • CHU Reims
        • Contact:
        • Principal Investigator:
          • Brigitte Delemer, Pr
        • Sub-Investigator:
          • Céline Lukas-Croisier, Dr
        • Sub-Investigator:
          • Maud François, Dr
        • Sub-Investigator:
          • Cédric Rakotondrantoanina, Dr
      • Rennes, France, 35000
        • Recruiting
        • Hopital Pontchaillou
        • Contact:
        • Principal Investigator:
          • Isabelle Guilhem, Dr
        • Sub-Investigator:
          • Christele Derrien, Dr
        • Sub-Investigator:
          • Agathe Guenego, Dr
        • Sub-Investigator:
          • Patricia Vaduva, Dr
        • Sub-Investigator:
          • Mathilde Fichet, Dr
        • Sub-Investigator:
          • Benjamin Moreau, Dr
      • Strasbourg, France, 67000
        • Recruiting
        • Hôpital Civil de Strasbourg
        • Contact:
        • Principal Investigator:
          • Nathalie Jeandider, Pr
        • Sub-Investigator:
          • Laurent Meyer, Dr
        • Sub-Investigator:
          • Marion Munch, Dr
      • Toulouse, France, 31400
        • Not yet recruiting
        • Hopital de Rangueil
        • Contact:
        • Principal Investigator:
          • Hélène Hanaire, Pr
        • Sub-Investigator:
          • Pierre Gourdy, Pr
        • Sub-Investigator:
          • Nelly Puech-Bret, Dr
        • Sub-Investigator:
          • Florence Labrousse-Lhermine, Dr
        • Sub-Investigator:
          • Maria Matta, Dr
        • Sub-Investigator:
          • Vincent Melki, Dr
        • Sub-Investigator:
          • Raquel Tirado Godas, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with type 1 diabetes equal or more than 18 years old, with Hb1Ac ≥ 8%

Description

Inclusion Criteria:

  • patients with type 1 diabetes;
  • patients who are at least 18 years old;
  • patients total daily dose required must be less than 90 units (U);
  • patients accepting to be treated with 100 U/mL rapid-acting insulin analog
  • patients having a HbA1c ≥ 8% despite of the use of a pump for at least 6 months
  • patients performing glucose self-monitoring several times ( ≥ 4) a day
  • patient accepting the technology
  • patients agreeing to use the system with activated loop mode during at least 75% of the
  • total time of use, this will be analyzed after 1 year of use.
  • patients must be affiliated to any kind of social security

Exclusion Criteria:

  • patients receiving a total daily dose of insulin lower than 8 U;
  • patients suffering from a serious illness or having a treatment that might significantly impair diabetes physiology (iSGLT2, steroids, metformin), i.e. glucose-insulin interactions, that might interfere with the medical device (for example treatment by steroids with variable dosage during the study period);
  • patients having severe uncorrected problems of hearing and/or visual acuity preventing proper use of DBLG1 System;
  • patients unable to understand and perform all of the instructions regarding the devices and the clinical investigation provided by Diabeloop.
  • patients planning to perform during the year of study repeated magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The G6 has not been tested in those situations. The magnetic fields and heat could damage the components of the Dexcom G6, which may cause it to display inaccurate sensor glucose readings (readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, patients might be exposed to severe low or high glucose events;
  • patients who are unwilling or unable to maintain contact with the healthcare professional;
  • patients willing to use any insulin that is not 100 U/mL rapid-acting insulin analog with the system (for example regular insulin; long-acting insulin analog; 200 U/mL rapid-acting insulin analog)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient with HbA1c >= 8% despite the use of insulin pump and frequent glycemic control
only group included in the study
Device: DBLG1 System
Use of DBLG1 System in real life condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
time in 70 - 180 mg/dL glycemic range
Time Frame: through study completion, an average of 1 year
Improvement of the time in glycemic range 70 - 180 mg/dL, in percentage, on 24hours and nighttime
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c HbA1c HbA1c
Time Frame: at the beginning and at the end of the study (1 year between each value)
change in the HbA1c after 1 year of use of the device
at the beginning and at the end of the study (1 year between each value)
mean CGM
Time Frame: through study completion, an average of 1 year
change of mean CGM glucose on 24hours and nighttime
through study completion, an average of 1 year
time in 70 - 140 mg/dL glycemic range
Time Frame: through study completion, an average of 1 year
change of time in 70 - 140 mg/dL range on 24hours and nighttime
through study completion, an average of 1 year
time in hypoglycemia
Time Frame: through study completion, an average of 1 year
change of time in hypoglycemia, under 70 mg/dL, 60 mg/dL and 50 mg/dL on 24hours and nighttime
through study completion, an average of 1 year
time in hyperglycemia
Time Frame: through study completion, an average of 1 year
change of time in hyperglycemia above 180 mg/dL, 250 mg/dL and 300 mg/dL on 24hours and nighttime
through study completion, an average of 1 year
use of loop mode
Time Frame: treatment period, an average of 1 year
percentage of time using activated loop mode vs. deactivated loop mode
treatment period, an average of 1 year
SD and CV of CGM values
Time Frame: through study completion, an average of 1 year
change of SD and CV of CGM values on 24hours and nighttime
through study completion, an average of 1 year
adverse event
Time Frame: through study completion, an average of 1 year
number of adverse events
through study completion, an average of 1 year
Health Survey
Time Frame: at the beginning and at the end of the study (1 year between each value)
change of the patient health, evaluated by questionnaire Short Form 12 Health Survey filled in at the beginning and at the end of the study
at the beginning and at the end of the study (1 year between each value)
Fear of hypoglycemia
Time Frame: at the beginning and at the end of the study (1 year between each value)
change of the patient fear of hypoglycemia, evaluated by questionnaire Hypoglycemia fear survey filled in at the beginning and at the end of the study
at the beginning and at the end of the study (1 year between each value)
Patient stress status
Time Frame: at the beginning and at the end of the study (1 year between each value)
change of the patient stress status, evaluated by questionnaire Diabetes distress scale, filled in at the beginning and at the end of the study
at the beginning and at the end of the study (1 year between each value)
Acceptability of the device
Time Frame: at the beginning and at the end of the study (1 year between each value)
change of the patient's satisfaction of previous vs. DBLG1 System devices, evaluated by questionnaire patient stress status, filled in at the beginning and at the end of the study
at the beginning and at the end of the study (1 year between each value)
incidence of the system on the necessary healthcare professional charge
Time Frame: through study completion, an average of 1 year
questionnaire at each visit (duration and type of visit, number and type of healthcare professional required for the visit)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diabeloop

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pauline Schaepelynck, APHM Hôpital Sud Sainte Marguerite
  • Principal Investigator: Hélène Hanaire, Chu Toulouse
  • Principal Investigator: Sandrine Lablanche, University Hospital, Grenoble
  • Principal Investigator: Alfred Penfornis, Ch Sud Francilien
  • Principal Investigator: Yves Reznik, CHU CAEN
  • Principal Investigator: Lucy Chaillous, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCB 2020-A 02808-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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