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Recurrent Hypoglycaemia in Type 1 Diabetes

NCT01337362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-10-16

No results posted yet for this study

Summary

Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines.

The purpose of the study is to investigate the activity in the brain, the cognitive function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The results will show whether the response to hypoglycaemia will change after repeated episodes.

It is our hope that results can contribute to improved understanding of hypoglycaemic EEG changes.

Conditions

  • Hypoglycaemia

Interventions

PROCEDURE

Insulin clamp

Patients will be exposed to low bloodsugar

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • UNEEG Medical A/S

    collaborator INDUSTRY

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Anne-Sophie Sejling, MD · Hillerod Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337362 on ClinicalTrials.gov