An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA) (INNODIA)

December 17, 2020 updated by: David Dunger, University of Cambridge

INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu).

The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium.

The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.

One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

Study Overview

Status

Status

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

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.

Detailed Description

This is a longitudinal observational study of the relationship between measures of β-cell function, genotype, immunological phenotype and potential environmental factors over time, in individuals with new onset T1D or first degree relatives at higher risk for T1D due to the presence of auto-antibodies.

It is a multicentre international study involving clinical centres across Europe which is unique in the following ways:

  1. The first such collaboration in Europe
  2. Novel evaluation of C-peptide/β-cell function using both home dried blood spots and regular hospital mixed meal tolerance tests or oral glucose tolerance tests
  3. Identical study procedures across all clinical centres
  4. Centralised analysis/storage of clinically relevant samples
  5. The creation of a living 'Biobank' whereby participants can be recalled for study on the basis of specific genotype/phenotypes
  6. Linkage to innovative study of novel biomarkers to inform future interventional strategies
  7. A potential pipeline for future recruitment and consent to novel innovative interventional strategies

The study is divided into 2 arms:

In arm A, the investigators plan to recruit 1500 newly diagnosed T1D patients within 6 weeks from diagnosis. The last study visit will be planned 2 years from diagnosis or until the end of the study. Therefore, the duration of the study will be approximately 2 years consisting of 5 visits. At baseline, C-peptide and immunophenotyping are evaluated. Follow up consists of regular mixed meal tolerance test (MMTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) pre and post a standardized meal will be collected monthly for the duration of the study.

These recruited participants will be included for further observational study, confirmation of potential biomarkers and will ultimately provide a pipeline for future recruitment to interventional studies.

In arm B, the investigators plan to screen approximately 4500 unaffected first degree family members across all centres during the first 3 years. The family members will be screened for 4 auto-antibodies (GAD65, IA-2A, IAA, ZnT8A).

Unaffected family members who are auto-antibody positive will be followed up for approximately 4 years consisting of visits every 6 months for the first 2 years and then every 12 months until the end of the study. Follow up will consist of regular oral glucose tolerance test (OGTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) will be collected monthly for the duration of the study.

Unaffected participants who are auto-antibody negative will be sent annual questionnaires until the end of the study.

All study participants will be consented to a living 'Biobank' where we will be able to request participants to be recalled by genotype/phenotype for further studies involving blood, urine and stool samples.

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 (Anticipated)

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.
6000

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.
  • Name: David B Dunger
  • Phone Number: +44 1223 336886
  • Email: dbd25@cam.ac.uk

Study Contact Backup

Study Locations

  • Austria
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Universitee Libre de Bruxelles
        • Contact:
      • Leuven, Belgium
  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • University of Copenhagen
        • Contact:
        • Principal Investigator:
          • Jesper Johannesen
        • Sub-Investigator:
          • Jannet Svensson
  • Finland
      • Helsinki, Finland
        • Recruiting
        • University of Helsinki
        • Contact:
        • Principal Investigator:
          • Mikael Knip
      • Oulu, Finland
        • Recruiting
        • University of Oulu
        • Contact:
        • Principal Investigator:
          • Riitta Veijola
      • Turku, Finland
        • Not yet recruiting
        • Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Jorma Toppari
  • France
      • Paris, France
        • Recruiting
        • Institut National de la santé et de la recherché Médicale (INSERM)
        • Contact:
        • Principal Investigator:
          • Roberto Mallone
  • Germany
      • Hanover, Germany
        • Recruiting
        • Children's Hospital Auf der Bult, Hannover Medical School
        • Contact:
      • Ulm, Germany
        • Recruiting
        • University of Ulm
        • Contact:
        • Principal Investigator:
          • Reinhard Holl
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • San Raffaele Hospital
        • Contact:
        • Principal Investigator:
          • Emauele Bosi
      • Rome, Italy
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù
        • Contact:
        • Principal Investigator:
          • Stefano Cianfarani
      • Siena, Italy
  • Luxembourg
      • Luxembourg, Luxembourg
        • Recruiting
        • University of Luxembourg
        • Contact:
        • Principal Investigator:
          • Carine De Beaufort
  • Norway
      • Oslo, Norway
  • Poland
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia Katowice
        • Contact:
        • Principal Investigator:
          • Przemyslawa Jarosz-Chobot
  • Slovenia
      • Ljubljana, Slovenia
        • Recruiting
        • University of Ljubljana
        • Contact:
        • Principal Investigator:
          • Tadej Battelino
  • Sweden
      • Malmö, Sweden
        • Recruiting
        • University of Lund
        • Contact:
        • Principal Investigator:
          • Markus Lundgren
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ

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

1 year to 44 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed patients with Type 1 diabetes.

Unaffected first degree family members of patients with type 1 diabetes.

Description

Newly diagnosed:

Inclusion Criteria:

  • Have given written informed consent to participate.
  • Be aged between 1 year and <45 years.
  • Less than 6 weeks from diagnosis of type 1 diabetes and requiring insulin treatment.

Exclusion Criteria:

  • Non-type 1 diabetes (type 2, monogenic diabetes and secondary diabetes)
  • Concurrent use of long term immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results.
  • Expected non-compliance with the protocol.
  • Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because problems in interpreting data or safety concern.
  • Participating in interventional or other drug research studies which could affect the primary objectives of the study.

Unaffected Family Members:

Inclusion Criteria:

  • Have given written informed consent to participate.
  • Be aged between 1 year and <45 years.
  • Have a first degree relative with type 1 diabetes (parent, child, full or half siblings) diagnosed <45 years of age

Exclusion Criteria:

  • The affected first degree relative has type 2 diabetes, monogenic diabetes or diabetes secondary to another medical condition.
  • Concurrent use of long term immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results.
  • Expected non-compliance with the protocol.
  • Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because problems in interpreting data or safety concern.
  • Participating in interventional or other drug research studies which could affect the primary objectives of the study.

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

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.
Newly Diagnosed (ND)
Recruited within 6 weeks of type 1 diabetes diagnosis. Age between 1 and <45 years
Unaffected Family members (UFM)

Participants who are not diabetic but have a first degree relative with type 1 diabetes diagnosed < 45 years of age.

Age between 1 and <45 years

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
Arm A - Newly Diagnosed people with Type 1 diabetes
Time Frame: 24 months
Rate of decline in Beta cell function as assessed by mixed meal tolerance test and home dried blood spot C-peptide measures over the first 24 months from diagnosis of Type 1 diabetes.
24 months
Arm B - Auto-antibody positive first degree family members
Time Frame: 48 months
Development of diabetes as defined by the American Diabetes Association in auto-antibody positive family members followed longitudinally.
48 months

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
Arm A - Newly diagnosed patients with Type 1 diabetes
Time Frame: 24 months
Changes in HbA1c, insulin dose, autoantibody levels over the first 24 months from diagnosis.
24 months
Arm A - Newly diagnosed patients with Type 1 diabetes - Systematic evaluation of biological samples
Time Frame: 24 months
Systematic evaluation of biological samples using multiple 'omics' approach to identify biomarkers which predict rate of deterioration in C-peptide measures
24 months
Arm A - Newly diagnosed patients with Type 1 diabetes - Framework
Time Frame: 24 months
To develop a robust observational framework for future interventional studies.
24 months
Arm B - Auto-antibody positive first degree family members - glucose tolerance
Time Frame: 48 months
Changes in glucose tolerance as determined by repeated oral glucose tolerance tests over the follow up period of 48 months
48 months
Arm B - Auto-antibody positive first degree family members - Systematic evaluation of biological samples
Time Frame: 48 months
Systematic evaluation of biological samples, using multiple 'omics' approach, auto antibodies to identify biomarkers which predict rate of progression to diabetes.
48 months
Arm B - Auto-antibody positive first degree family members - Framework
Time Frame: 48 months
Developing a robust framework for future interventional studies.
48 months

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.
University of Cambridge

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Juvenile Diabetes Research Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
Innovative Medicines Initiative

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: David B Dunger, University of Cambridge
  • Principal Investigator: Mikael Knip, University of Helsinki
  • Study Chair: Chantal Mathieu, Katholieke Universteit Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 14, 2016

Primary Completion (ANTICIPATED)

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.
October 31, 2022

Study Completion (ANTICIPATED)

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.
October 31, 2022

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).
March 21, 2019

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.
April 30, 2019

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.
May 3, 2019

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.
December 21, 2020

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.
December 17, 2020

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.
December 1, 2020

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.
  • INNODIA 01
  • 210497 (OTHER: IRAS Project ID)
  • 115797 (OTHER_GRANT: Innovative Medicines Initiative)

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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