Foot Deformities clinical trials

Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4

The overall objective of this project is to describe the prevalence of and risk factors to diabetic neuropathy in a representative cohort of diabetes patients and to investigate pathophysiological conditions in those patients with neuropathy. This project will yield substantial new knowledge about the prevalence of diabetic neuropathy in type 1 and type 2 DM persons, new risk factors to neuropathy and the association to other diabetic complications. Findings related to the study may facilitate new treatment regimens prompting a better neuropathy treatment with reduced incidence of diabetic complications. First patients at SDCC will be screened for diabetic neuropathy (Study 1.1) with an extended neuropathy screening program as an addition to the routine neuropathy screening at SDCC. 1000 patients with type 1 DM and 1000 patients with type 2 DM will be included. This screening study is a prerequisite for the further study of study participants in substudies investigating associations between diabetic neuropathy and diabetic complications as described below. Hypothesis: Several patients with diabetes have undiagnosed neuropathy and associated diabetic complications. We hypothesize that diabetic neuropathy is underdiagnosed at SDCC and can be diagnosed with targeted screening with new and traditional measuring techniques. In addition, several patients may have complications related to neuropathy, including foot complications, and dysregulation of glucose metabolism Aim: This study consists of a screening study (study 1.1) and two substudies (1.2 and 1.3 ). Study 1.1 is a cross-sectional study describing the prevalence of diabetic neuropathy based on questionnaire data and objective measures as described below and associated diabetic complications including foot complications. The primary aim is to explore the prevalence of diabatic neuropathy in patients with type 1 and type 2 DM at SDCC and secondarily to explore associations between diabetic neuropathy and complications, as described in the respective sections below. The substudy 1.2 is an observational single center cohort study with the aim of investigating associations between neuropathy diagnosed with new devices for measurement of neuropathy and foot complications in patients with type 1 and type 2 diabetes. The substudy 1.3 is an observational single center cohort study investigating the association between CAN and glycemic variability in patients with type 1 diabetes.