Islet Autoantibody Clinical Trial Enrichment Tool
What the tool is:
A quantitative clinical trial enrichment tool to help optimize clinical trial design for therapies to prevent or delay diagnosis of T1D, using islet AAs with other relevant clinical features. Access the tool and read more about it by clicking the button below.
New Onset Clinical Trial Simulation Tool (In Development)
A model-based clinical trial simulation platform describing the progression of new onset T1D comprising four individual drug-disease-trial models that measure: C-peptide area under the time-concentration curve (AUC) during the 2-hour mixed-meal tolerance test (MMTT), glucose concentrations measured by AUC during 2-hour MMTT, insulin use over time, and HbA1c %. Models of each measure will incorporate relevant sources of variability, including age at diagnosis, length of time since diagnosis, sex, body mass index (BMI), insulin use, and baseline values for C-peptide and glucose as measured through 2-hour MMTT and HbA1c. This tool can be used to perform clinical trial simulations to inform trial design, including inclusion or exclusion criteria, enrichment, and stratification approaches for individuals within 100 days of T1D diagnosis.
Prevention Clinical Trial Simulation Tool (In Development)
A model-based simulation platform describing the progression to T1D comprising of joint models using disease progression models that measure HbA1c (%), glucose area under the curve and C-peptide area under the curve during the 2-hour oral glucose tolerance test, and a time-to-T1D diagnosis model. Models will incorporate relevant sources of variability, including sex, race, BMI, age at study entry, HLA genotype, and the presence, order of detection, and time-course for the appearance of islet autoantibodies (AAs). This tool can be used to perform clinical trial simulations to inform trial design-including trial duration, inclusion or exclusion criteria, enrichment, and stratification approaches for individuals at risk of T1D, defined as being a first degree relative of a T1D patient, or having a specific HLA subtype of risk (HLA-DR3/3, DR4/4, DR3/4, DR3/X [X≠3], DR4/X [X≠4]).
C-Path Receives Qualification Opinion from EMA on Type 1 Diabetes Biomarker Initiative
C-Path’s Type 1 Diabetes Consortium has been issued a positive qualification opinion for pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) prevention trials from the European Medicines Agency (EMA). The purpose of this model-based qualification is to make publicly available tools to assist in the identification and selection of patients with a likelihood of progressing to a T1D clinical diagnosis in a trial of reasonable duration. Full details, here.
C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative
On April 28, 2020, C-Path announced that its Type 1 Diabetes (T1D) Consortium received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials. For more information, see the document linked below: