An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 19
- 主要终点
- Arm A - Newly Diagnosed people with Type 1 diabetes
研究概览
简要总结
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.
详细描述
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:
- The first such collaboration in Europe
- 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
- Identical study procedures across all clinical centres
- Centralised analysis/storage of clinically relevant samples
- The creation of a living 'Biobank' whereby participants can be recalled for study on the basis of specific genotype/phenotypes
- Linkage to innovative study of novel biomarkers to inform future interventional strategies
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Arm A - Newly Diagnosed people with Type 1 diabetes
时间窗: 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.
Arm B - Auto-antibody positive first degree family members
时间窗: 48 months
Development of diabetes as defined by the American Diabetes Association in auto-antibody positive family members followed longitudinally.
次要结局
- Arm B - Auto-antibody positive first degree family members - Framework(48 months)
- Arm B - Auto-antibody positive first degree family members - Systematic evaluation of biological samples(48 months)
- Arm A - Newly diagnosed patients with Type 1 diabetes(24 months)
- Arm A - Newly diagnosed patients with Type 1 diabetes - Framework(24 months)
- Arm B - Auto-antibody positive first degree family members - glucose tolerance(48 months)
- Arm A - Newly diagnosed patients with Type 1 diabetes - Systematic evaluation of biological samples(24 months)
研究者
David Dunger
Professor of Paediatrics
University of Cambridge