PRÊT1D – National pilot project for the screening and management of preclinical T1DM

 

Background

The recently published French position paper SFD/SFEDP provides us with an initial frame of reference for the screening and management of preclinical T1DM in relatives of T1DM patients. In addition, new ICD-10 diagnostic codes have been created for Stage 1 (E10.A1) and Stage 2 (E10.A2) T1DM, suggesting that the management of preclinical T1DM, following screening, is preparing to move into routine care.

The PRÊT1D study, promoted by the Fondation Francophone pour la Recherche sur le Diabète (FFRD ), aims to remove 3 barriers to the development of this new patient pathway:

 

1) Access to screening

PRÊT1D proposes to simplify this volumetrically more important step, taking it out of the hands of hospitals and private practices, by using capillary samples that can be collected independently at home and sent by post to a centralized screening laboratory at the Cochin Hospital. Here, the A-4 autoantibodies of T1DM (IAA, GAD, IA-2, ZnT8) are measured using a validated ADAP assay. Each screening result is then communicated to the referral center, so that the participant can be informed and organize his monitoring in accordance with the French position. An option for sampling by healthcare professionals in participating centers is also available.

 

 

2) Harmonized care treatment and management

The creation of a harmonized follow-up and care pathway for relatives with a positive screening test. Bu the end, PRÊT1D is proposing to simplify the process, using a digital health platform developed with startup Ailin. This platform will include 3 modules:

  • a) a clinical dashboard for professionals, centralizing screening requests, results and follow-up with an individual, family and global vision, and proposing medical decision support algorithms;
  • b) a mobile application for patients, a tool for active engagement, facilitating direct patient/expert center contact and offering information support and automated reminders;
  • c) a research registry, a pseudonymized database covering the prevalence/natural history of preclinical T1DM, the acceptability/feasibility of screening and the cost of screening/follow-up.

 

3) Long-term economic viability

PRÊT1D proposes to collect the data needed to discuss reimbursement options with the HAS using an interface with the SFDT1 cohort, a study also promoted by the Fondation Francophone pour la Recherche sur le Diabète (FFRD) since 2019. This interface will make it possible to track individuals who have progressed to clinical T1DM and compare them with those diagnosed without screening, at the time of clinical declaration and then at a distance: glycemic control and micro/macroangiopathic complications via the SFDT1costs incurred/avoided via SNDS data not available in other countries.

 

This national pilot project (29 centers by 12/25/2025) will be rolled out in 2 steps:

Step 1

On a small scale: 2,900 screenings/year for around 12 months through the INNODIA Detect protocol, scheduled to start up in January 2026.

Step 2

On a larger scale: 7,500 screenings/year for 4 years, through the PRÊT1Dprotocol, which will gradually follow.