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Type 1 Diabetes MellitusINNODIANCT03936634

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

An observational study of Type 1 Diabetes Mellitus, run by University of Cambridge at 19 sites in 13 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 year to 44 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
How many people
6,000 participants
Where
19 sitesin 13 countries
Study dates
14 Nov 2016to 31 Oct 2022
How long will I take part?
2 Years
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 1 year to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Newly diagnosed patients with Type 1 diabetes. Unaffected first degree family members of patients with type 1 diabetes.

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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:
Show all 11Show fewer
  • 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.

Trial locations and contacts

19 sites in 13 countries.

David B Dunger contact

+44 1223 336886

dbd25@cam.ac.uk

Sylvaine Bruggraber contact

+44 1223 769063

sb2194@medschl.cam.ac.uk

19 sites in 13 countries

Finland3 sites, 3 recruiting

  • University of Helsinki

    Helsinki

    Recruitment queries, pedia-innodia@helsinki.fi

    Mikael Knip

    Recruiting

  • University of Oulu

    Oulu

    Riitta Veijola, riitta.veijola@oulu.fi

    Riitta Veijola

    Recruiting

  • Turku University Hospital

    Turku

    Jorma Toppari, jorma.toppari@utu.fi

    Jorma Toppari

    Not yet recruiting

Other trials in Finland

Italy3 sites, 3 recruiting

  • San Raffaele Hospital

    Milan

    Pauline Grogan, grogan.pauline@hsr.it

    Emauele Bosi

    Not yet recruiting

  • Ospedale Pediatrico Bambino Gesu

    Rome

    Valentina Pampanini, valentina.pampanini@opbg.net

    Stefano Cianfarani

    Recruiting

  • University of Studi di Siena

    Siena

    Francesco Dotta, francesco.dotta@unisi.it

    Francesco Dotta

    Recruiting

Other trials in Italy

Belgium2 sites, 2 recruiting

  • Universitee Libre de Bruxelles

    Brussels

    Miriam Cnop, mcnop@ulb.ac.uk

    Miriam Cnop

    Recruiting

  • Katholieke Universiteit Leuven

    Leuven

    Chantal Mathieu, chantal.mathieu@kuleuven.be

    Kristina Casteels, kristina.casteels@kuleuven.be

    Recruiting

Other trials in Belgium

Germany2 sites, 2 recruiting

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

    Hanover

    Recruitment queries, innodia@hka.de

    Thomas Danne

    Recruiting

  • University of Ulm

    Ulm

    Reinhard Holl, reinhard.holl@uni-ulm.de

    Stefanie Lanzinger, stefanie.lanzinger@uni-ulm.de

    Recruiting

Other trials in Germany

Austria1 site, 1 recruiting

  • Medical University of Graz

    Graz

    Thomas Pieber, thomas.pieber@medunigraz.at

    Gerlies Treiber, gerlies.treiber@medunigraz.at

    Recruiting

Other trials in Austria

Denmark1 site, 1 recruiting

  • University of Copenhagen

    Copenhagen

    Jesper Johannesen, jesper.johannesen@regionh.dk

    Jesper Johannesen

    Recruiting

Other trials in Denmark

France1 site, 1 recruiting

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

    Paris

    Recruitment queries, trakrstudy@gmail.com

    Roberto Mallone

    Recruiting

Other trials in France

Luxembourg1 site, 1 recruiting

  • University of Luxembourg

    Luxembourg

    Carine De Beaufort, debeaufort.carine@chl.lu

    Carine De Beaufort

    Recruiting

Other trials in Luxembourg

Norway1 site, 1 recruiting

  • Oslo Universitetssytehus HF

    Oslo

    Knut Dahl-Jørgensen, knut.dahl-jorgensen@medisin.uio.no

    Knut Dahl-Jørgensen

    Recruiting

Other trials in Norway

Poland1 site, 1 recruiting

  • Medical University of Silesia Katowice

    Katowice

    Przemyslawa Jarosz-Chobot, przemka1@o2.pl

    Przemyslawa Jarosz-Chobot

    Recruiting

Other trials in Poland

Slovenia1 site, 1 recruiting

  • University of Ljubljana

    Ljubljana

    Darja Smigoc, darja.smigoc@kclj.si

    Tadej Battelino

    Recruiting

Other trials in Slovenia

Sweden1 site, 1 recruiting

  • University of Lund

    Malmö

    Linda Ahlkinst, linda.ahlkvist@med.lu.se

    Markus Lundgren

    Recruiting

Other trials in Sweden

United Kingdom1 site, 1 recruiting

  • University of Cambridge

    Cambridge, CB2 0QQ

    Recruitment queries, INNODIA-recruit@paed.cam.ac.uk

    Ajay Thankamony

    Recruiting

Other trials in United Kingdom

About this study

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.

Read more

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.

Read the 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.

Keywords
Observation study, First degree relatives, Beta cell, C-Peptide, Immune cells, Disease progression
Medical subject headings
Diabetes Mellitus, Type 1, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03936634
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm A - Newly Diagnosed people with Type 1 diabetes

    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.

    Measured: 24 months

  2. Arm B - Auto-antibody positive first degree family members

    Development of diabetes as defined by the American Diabetes Association in auto-antibody positive family members followed longitudinally.

    Measured: 48 months

Secondary outcomes (6)

  1. Arm A - Newly diagnosed patients with Type 1 diabetes

    Changes in HbA1c, insulin dose, autoantibody levels over the first 24 months from diagnosis.

    Measured: 24 months

  2. Arm A - Newly diagnosed patients with Type 1 diabetes - Systematic evaluation of biological samples

    Systematic evaluation of biological samples using multiple 'omics' approach to identify biomarkers which predict rate of deterioration in C-peptide measures

    Measured: 24 months

  3. Arm A - Newly diagnosed patients with Type 1 diabetes - Framework

    To develop a robust observational framework for future interventional studies.

    Measured: 24 months

  4. Arm B - Auto-antibody positive first degree family members - glucose tolerance

    Changes in glucose tolerance as determined by repeated oral glucose tolerance tests over the follow up period of 48 months

    Measured: 48 months

  5. Arm B - Auto-antibody positive first degree family members - Systematic evaluation of biological samples

    Systematic evaluation of biological samples, using multiple 'omics' approach, auto antibodies to identify biomarkers which predict rate of progression to diabetes.

    Measured: 48 months

  6. Arm B - Auto-antibody positive first degree family members - Framework

    Developing a robust framework for future interventional studies.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start14 Nov 2016
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936634
Sponsor's protocol ID
INNODIA 01
Other IDs
210497, 115797
Acronym
INNODIA
Status last verified
Dec 2020
First submitted
21 Mar 2019
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andellini M, Haleem S, Angelini M, Ritrovato M, Schiaffini R, Iadanza E, Pecchia L. Artificial intelligence for non-invasive glycaemic-events detection via ECG in a paediatric population: study protocol. Health Technol (Berl). 2023;13(1):145-154. doi: 10.1007/s12553-022-00719-x. Epub 2023 Jan 23.

    PubMed 36761922

  • Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobe H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669.

    PubMed 34876434

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by University of Cambridge at 19 sites in 13 countries.

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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Finland, Italy, Belgium, Germany, Austria and 8 more countries. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David B Dunger (+44 1223 336886, dbd25@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A - Newly Diagnosed people with Type 1 diabetes (time frame: 24 months). 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 NCT03936634, which also lists 2 linked publications.

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 21 Dec 2020.

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