Study identification

EU PAS number

EUPAS1000000756

Study ID

1000000756

Official title and acronym

DARWIN EU® - Feasibility of studies on early (pre-symptomatic) stages of type 1 diabetes mellitus in the DARWIN EU® network

DARWIN EU® study

Yes

Study countries

Denmark
Finland
France
Hungary
Netherlands
Spain

Study description

Identifying type 1 diabetes mellitus at an early, presymptomatic stage offers clinical advantages. These benefits include a decreased risk of diabetic ketoacidosis (DKA) at the onset of the disease and a notable reduction in clinical symptoms. Additionally, products such as Tzield (teplizumab) are being developed to target early stages of type 1 diabetes mellitus, aiming to delay disease progression. There is also increasing attention in clinical practice to early screening (via specific antibodies), which helps in identifying candidates for disease-modifying therapies and provides early access to diabetes-related education and disease management.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Julieta Politi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable