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

Last updated: December 17, 2020
Sponsor: University of Cambridge
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT03936634
INNODIA 01
210497
115797
  • Ages 1-44
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Non-type 1 diabetes (type 2, monogenic diabetes and secondary diabetes)
  • Concurrent use of long term immunosuppressive agents including oral steroids ormedication 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 principalinvestigator and/or co-investigator to make the patient ineligible for inclusionbecause problems in interpreting data or safety concern.
  • Participating in interventional or other drug research studies which could affect theprimary 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 halfsiblings) diagnosed <45 years of age Exclusion Criteria:
  • The affected first degree relative has type 2 diabetes, monogenic diabetes or diabetessecondary to another medical condition.
  • Concurrent use of long term immunosuppressive agents including oral steroids ormedication 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 principalinvestigator and/or co-investigator to make the patient ineligible for inclusionbecause problems in interpreting data or safety concern.
  • Participating in interventional or other drug research studies which could affect theprimary objectives of the study.

Study Design

Total Participants: 6000
Study Start date:
November 14, 2016
Estimated Completion Date:
October 31, 2022

Study 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.

Connect with a study center

  • Medical University of Graz

    Graz,
    Austria

    Active - Recruiting

  • Universitee Libre de Bruxelles

    Brussels,
    Belgium

    Active - Recruiting

  • Katholieke Universiteit Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • University of Copenhagen

    Copenhagen,
    Denmark

    Active - Recruiting

  • University of Helsinki

    Helsinki,
    Finland

    Active - Recruiting

  • University of Oulu

    Oulu,
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku,
    Finland

    Site Not Available

  • Institut National de la Sante et de la Recherche Medicale (INSERM)

    Paris,
    France

    Active - Recruiting

  • Children's Hospital Auf der Bult, Hannover Medical School

    Hanover,
    Germany

    Active - Recruiting

  • University of Ulm

    Ulm,
    Germany

    Active - Recruiting

  • San Raffaele Hospital

    Milan,
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesu

    Rome,
    Italy

    Active - Recruiting

  • University of Studi di Siena

    Siena,
    Italy

    Active - Recruiting

  • University of Luxembourg

    Luxembourg,
    Luxembourg

    Active - Recruiting

  • Oslo Universitetssytehus HF

    Oslo,
    Norway

    Active - Recruiting

  • Medical University of Silesia Katowice

    Katowice,
    Poland

    Active - Recruiting

  • University of Ljubljana

    Ljubljana,
    Slovenia

    Active - Recruiting

  • University of Lund

    Malmö,
    Sweden

    Active - Recruiting

  • University of Cambridge

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.