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

Summary

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.

Conditions

• Diabetic Neuropathies
• Distal Peripheral Sensory Neuropathy
• Diabetic Foot
• Foot Deformities
• Autonomic Neuropathy
• CAN

Interventions

DEVICE

Vagus

Cardiovascular autonomic neuropathy (Vagus) both resting heart rate variability and cardiovascular reflex tests The examination consists of 4 measures, all aimed at measuring heart rate. Measurements are taken for 5 minutes rest, change of position from lying to standing position, during deep breathing and by Valsalva (by breathing in a mouthpiece with a 40 mmHg resistance).

DEVICE

HeartsTrends

• Cardiovascular autonomic neuropathy (HeartTrends®) measurers 60-minutes heart rate variability via a chest belt electrode (a Holter monitor) and an external data acquisition device.

DEVICE

Sudoscan

Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance in hands and feet

DEVICE

UllMeter

• Pressure pain sensitivity of the chest bone is recorded (with a device which has the size and shape as a pen)during rest as a measure for sympathetic autonomic activity of the brain (UllMeter®) (www.stressmeter.org)

DEVICE

DPN-check

Nerve conduction velocity and amplitude of the Sural nerves by DPN-check

DEVICE

Rolltemp

Cold and warm sense of foot and lower leg

DEVICE

Dexcom G6 Device

Insertion of continuous glucose monitor ( The Dexcom G6 Device) After 10 days in the study the patient will return the glucose monitor and diary by prepaid mail. Glycemic variability and hypoglycemia duration will be calculated from CGM data. Glycemic variability will be assessed by standard deviation (SD) and Coefficient of Variance (CV). We define normo-glycemic range as sensor glucose between 4.0 and 10.0 mmol/L. Hypoglycemia will be defined in two ranges as SG ≤3.9 mmol/L or SG ≤3.0 mmol/L). An episode of hypoglycemia will be defined as at least 15 minutes with SG below 3.9 mmol/L or 3.0 mmol/L, respectively. CGM recordings with less than 72 hours of data will be excluded from analysis.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2019-10-18

Completion

2022-12-31

Countries

• Denmark

Study Locations