An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)
NCT ID: NCT03936634
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
6000 participants
OBSERVATIONAL
2016-11-14
2022-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly Diagnosed (ND)
Recruited within 6 weeks of type 1 diabetes diagnosis. Age between 1 and \<45 years
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
* 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.
1 Year
44 Years
ALL
Yes
Sponsors
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Innovative Medicines Initiative
OTHER
Juvenile Diabetes Research Foundation
OTHER
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
University of Cambridge
OTHER
Responsible Party
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David Dunger
Professor of Paediatrics
Principal Investigators
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David B Dunger
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Mikael Knip
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki
Chantal Mathieu
Role: STUDY_CHAIR
Katholieke Universteit Leuven
Locations
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Medical University of Graz
Graz, , Austria
Universitee Libre de Bruxelles
Brussels, , Belgium
Katholieke Universiteit Leuven
Leuven, , Belgium
University of Copenhagen
Copenhagen, , Denmark
University of Helsinki
Helsinki, , Finland
University of Oulu
Oulu, , Finland
Turku University Hospital
Turku, , Finland
Institut National de la Sante et de la Recherche Medicale (INSERM)
Paris, , France
Children's Hospital Auf der Bult, Hannover Medical School
Hanover, , Germany
University of Ulm
Ulm, , Germany
San Raffaele Hospital
Milan, , Italy
Ospedale Pediatrico Bambino Gesu
Rome, , Italy
University of Studi di Siena
Siena, , Italy
University of Luxembourg
Luxembourg, , Luxembourg
Oslo Universitetssytehus HF
Oslo, , Norway
Medical University of Silesia Katowice
Katowice, , Poland
University of Ljubljana
Ljubljana, , Slovenia
University of Lund
Malmo, , Sweden
University of Cambridge
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Thomas Pieber
Role: primary
Gerlies Treiber
Role: backup
Miriam Cnop
Role: primary
Chantal Mathieu
Role: primary
Kristina Casteels
Role: backup
Jesper Johannesen
Role: primary
Recruitment queries
Role: primary
Riitta Veijola
Role: primary
Jorma Toppari
Role: primary
Recruitment queries
Role: primary
Recruitment queries
Role: primary
Reinhard Holl
Role: primary
Stefanie Lanzinger
Role: backup
Pauline Grogan
Role: primary
Valentina Pampanini
Role: primary
Francesco Dotta
Role: primary
Carine De Beaufort
Role: primary
Knut Dahl-Jørgensen
Role: primary
Przemyslawa Jarosz-Chobot
Role: primary
Darja Smigoc
Role: primary
Linda Ahlkinst
Role: primary
Recruitment queries
Role: primary
References
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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.
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.
Other Identifiers
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210497
Identifier Type: OTHER
Identifier Source: secondary_id
115797
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
INNODIA 01
Identifier Type: -
Identifier Source: org_study_id