Clinical validation – randomised trials and interventions

LUDC-IRC takes advantage of the accumulated expertise of investigators and resources available to conduct recall trials based on pathogenetically relevant biomarkers or genotypes or based upon subtype of diabetes.

Work package 8 has access to  unique, large-scale clinical cohorts that include patients with diabetes and diabetes-associated complications, such as the All New Diabetics In Scania (ANDIS) cohort. The large accessible cohorts from which participants can be recalled and the excellent metabolic research facilities makes it possible to perform studies to validate potential markers of disease progression or markers of response to treatment or other interventions. 

Objectives

• To provide a platform and accumulated expertise for proof of concept trials originated from discoveries within LUDC-IRC.
• To provide a platform and accumulated expertise for prevention and intervention clinical trials, including evaluation of new therapies and life-style interventions.
• To generate new samples for the discovery of dynamic biomarkers (i.e., a biomarker that captures the drug response and allows for accurate estimations of long-term drug efficacy).

Selected publications

• Title: Absence of Islet Autoantibodies and Modestly Raised Glucose Values at Diabetes Diagnosis Should Lead to Testing for MODY: Lessons From a 5-Year Pediatric Swedish National Cohort Study
  Reference: Diabetes Care, 431 (1), 82-89 (2020)
• Title: Monogenic Diabetes: From Genetic Insights to Population-Based Precision in Care. Reflections From a Diabetes Care Editors' Expert Forum
  Reference: Diabetes Care, 43 (12), 3117-3128 (2020)
• Title: Beta cell function in participants with single or multiple islet autoantibodies at baseline in the TEDDY Family Prevention Study: TEFA
  Reference: Endocrinology, Diabetes & Metabolism, 4, e00198 (2021)
• Title: Normative values of the vibration perception thresholds at finger pulps and metatarsal heads in healthy adults
  Reference: PLoS One, 16 (4), e0249461 (2021)
• Title: Heterogeneity of beta-cell function in subjects with multiple islet autoantibodies in the TEDDY family prevention study – TEFA
  Reference: Clinical Diabetes and Endocrinology, 7:23 (2021)