Defining pathways for development of disease-modifying therapies in children with type 1 diabetes: a consensus report

Diabetes Care. 2015 Oct;38(10):1975-85. doi: 10.2337/dc15-1429.

Abstract

Emerging data suggest that type 1 diabetes is a more aggressive disease in children than in adults, with important differences in pathophysiology and clinical course. Therefore, the efficacy of disease-modifying therapies may be different in the two populations. Understanding the developmental and regulatory pathways for type 1 diabetes-modifying therapies in children will enable industry, academia, funders, advocacy groups, and regulators to translate new science to clinical care. This consensus report characterizes the fundamental differences in type 1 diabetes between children and adults and proposes a thoughtful approach to better understand the development and regulatory pathways for type 1 diabetes therapies.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adult
  • Age Factors
  • Child
  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / methods
  • Cognition Disorders / etiology
  • Consensus
  • Cost of Illness
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / complications
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Disease Progression
  • Ethics, Medical
  • Glycated Hemoglobin / metabolism
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / metabolism
  • Insulin Secretion
  • Orphan Drug Production
  • Quality of Life
  • Treatment Outcome

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin