The Need for Early-Stage T1D Detection

To advance the development of disease modifying therapies for T1D it is critical to identify individuals in the early stages of T1D (Stage 1 and 2) and to support a smooth transition towards the integration of early-stage T1D detection activities into national clinical practice. To this end, INNODIA has developed the INNODIA Family & Friends Early-Stage T1D Detection Program (INNODIA DETECT)—a clinical center-based initiative designed to screen relatives and friends of individuals diagnosed with symptomatic T1D. (Click here for the full rationale)

T1D StagesThe Stages of T1D – Just a small proportion of people with genetic risk of T1D progress to immune activation and immune response. Once two or more islet-autoantibodies are confirmed (Stage 1 T1D) it is nearly certain that progression will occur during the person's lifetime.                             

*Activation of the autoimmune response is manifested by the presence of circulating islet-autoantibodies (IAbs).

 

How INNODIA DETECT Works

INNODIA DETECT will provide INNODIA clinical site Members with: (i) master protocols for islet auto-antibody (IAb) detection and monitoring of IAb+ individuals, (ii) access to a centralized data repository (INNODIA electronic Case Report Form, eCRF) for streamlined data collection, and (ii) matchmaking support to connect clinical trials' Sponsors with clinical sites monitoring pre-symptomatic T1D individuals. INNODIA will also provide activated member sites with starting kits to identify individuals with T1D IAb.

While we work on activating all INNODIA clinical sites for INNODIA DETECT, we are making the master protocols and a standardized data collection file available for use:

Below are the key master protocols for early-stage T1D detection and monitoring:

 

Implementation at your clinical site while waiting for full activation

While INNODIA is in the process of activating member clinical sites across Europe, we recognize the importance of leveraging momentum at its peak. Whether your site is:

  • an INNODIA Member awaiting DETECT to be activated 
  • an INNODIA member that is not eligible for the activation of DETECT
  • not an INNODIA member

We aim to empower all clinical sites that are interested in early T1D detection to begin implementation immediately. We encourage all sites to adopt the INNODIA IAb Detect and IAb+ Monitor Master Protocols with necessary adaptations (e.g., conducting IAb diagnostic testing according to local practices) and to collect data using the provided file (link coming soon), even as formal approvals are underway.

Here’s our suggested course of action. Based on the results of your IAb diagnostic test:

  • IAb+ individuals → Record data from these individuals in the provided excel file and proceed to monitor them according to the IAb+ Monitor Master Protocol.
  • IAb- individuals → Record data from these individuals in the provided excel file. Once your center is officially activated within INNODIA DETECT, eligible individuals can be recontacted for further IAb testing.

Data collected via the excel file will seamlessly transition into the INNODIA eCRF once the site is fully activated. By taking this proactive approach, we ensure that, by the time an INNODIA clinical site Member is officially activated, INNODIA can provide immediate support as a centralized data collector, facilitating a smoother and more efficient transition.

  • Are you a European clinical site interested in joining INNODIA DETECT but not yet a member of the network? Click here to learn more about membership!
  • Are you a clinical site outside Europe looking for guidance on Early T1D Screening? You are in the right place. Our master protocols are free to download for all clinical sites.

How do we use the data of Stage 1 and Stage 2 individuals identified at INNODIA clinical sites through INNODIA DETECT: INNODIA as a Matchmaker

INNODIA Matchmaker

When medicine developers reach out with clinical trial opportunities for presymptomatic T1D people, INNODIA will connect them with the clinical sites where these individuals have been identified to facilitate their participation in the trials.

 

[1] Phillip M, Achenbach P, et al. Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes. Diabetes Care. 2024 Nov 1;47(11):2033. doi: 10.2337/dc24-er11a. PMID: 38912694; PMCID: PMC11381572. 
[2] Haller MJ, Bell KJ, et al. ISPAD Clinical Practice Consensus Guidelines 2024: Screening, Staging, and Strategies to Preserve Beta-Cell Function in Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr. 2024;97(6):529-545. doi: 10.1159/000543035. Epub 2024 Dec 11. PMID: 39662065; PMCID: PMC11854978.

 

IAb DETECT Infographics

INNODIA Matchmaker


 

IAb+ Monitor Infographics

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