NCT01237509

Brief Summary

Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of slow frequency waves. In a recent study the investigators have shown that these changes can be recorded from subcutaneous electrodes and processed by an automated mathematical algorithm based on non-linear spectral analysis, and that changes are present before the occurrence of severe hypoglycaemia in type 1 diabetes patients. An alarm device based on real-time analysis of continuous EEG-recordings may thus be possible. For many diabetes patients nocturnal hypoglycaemia is a feared complication which may thus be preventable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
Last Updated

March 20, 2015

Status Verified

November 1, 2010

Enrollment Period

1.1 years

First QC Date

November 8, 2010

Last Update Submit

March 19, 2015

Conditions

Sleep EEG

Keywords

EEGSleepdevicediabeteshypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Hypoglycaemia associated EEG changes during sleep

    24 hours

Study Arms (1)

group1

Patients with T1D

Device: Hypo device

Interventions

Hypo deviceDEVICE
group1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetes

You may qualify if:

  • Type 1 diabetes patients
  • Hypoglycemia unawareness
  • aged 18-70

You may not qualify if:

  • Severe cardiac disease
  • History of myocardial infarction
  • Cardiac arrhythmia
  • Previous stroke or cerebral haemorrhage and any other structural cerebral disease
  • Active cancer or cancer diagnosis within the past five years
  • Uremia defined as s-creatinine above 3 times upper reference value
  • Liver disease defined as s-ALAT above 3 times upper reference interval
  • Inability to understand the informed consent
  • Epilepsy
  • Use of antiepileptic drugs for any purposes
  • Clinical important hearing impairment
  • Use of active implantable medical device including
  • Pacemaker and ICD-unit
  • Cochlear implant
  • Use of following drugs
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esbjerg Sygehus

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

March 20, 2015

Record last verified: 2010-11

Locations

DK(1)