NCT01337362

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

March 30, 2011

Last Update Submit

October 15, 2014

Conditions

Hypoglycaemia

Keywords

DiabetesHypoglycaemiaEEGThermographyHypoglycaemia-associated autonomic failureQTc intervalHypoglycemic alarm deviceHormone response

Outcome Measures

Primary Outcomes (1)

  • EEG

    EEG will be analysed in order to see whether there are any differences between aware and unaware patients during hypoglycaemia. It is our hope that the result can help develop an alarm before the patient experiences severe hypoglycaemia.

    2 years

Secondary Outcomes (4)

  • QTc interval

    2 years

  • Skin temperature

    2 years

  • Auditory evoked potentials

    2 years

  • Cognitive function

    2 years

Study Arms (2)

Patients with hypoglycemia awareness

ACTIVE COMPARATOR

Patients who have symptoms when the blood sugar level is low

Procedure: Insulin clamp

patients with hypoglycaemic unawareness.

EXPERIMENTAL

Patients who do not feel any symptoms when the blood sugar levels are low

Procedure: Insulin clamp

Interventions

Insulin clampPROCEDURE

Patients will be exposed to low bloodsugar

Also known as: Insulin, clamp
Patients with hypoglycemia awarenesspatients with hypoglycaemic unawareness.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Age \> 18 years
  • \- Have had diabetes for more than 5 years
  • Negative pregnancy test
  • Caucasian
  • Signed written informed consent

You may not qualify if:

  • Pregnant or breastfeeding
  • Epilepsy
  • Self-perceived impaired hearing
  • Use of antiepileptic medicine
  • Use of neuroleptics within the last 6 months
  • Use of benzodiazepines within the last month
  • Use of betablockers
  • Previous stroke or other disease in the brain
  • Cardiovascular disease
  • Alcohol-, drug- or medicine abuse
  • Previous allergic reaction to heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerod Hospital

Hillerød, Hillerød, 3400, Denmark

Location

Related Publications (2)

  • She R, Al-Sari NH, Mattila IM, Sejling AS, Pedersen J, Legido-Quigley C, Pedersen-Bjergaard U. Decreased branched-chain amino acids and elevated fatty acids during antecedent hypoglycemia in type 1 diabetes. BMJ Open Diabetes Res Care. 2023 Jun;11(3):e003327. doi: 10.1136/bmjdrc-2023-003327.

    PMID: 37369531DERIVED

  • Rubega M, Sparacino G, Sejling AS, Juhl CB, Cobelli C. Hypoglycemia-Induced Decrease of EEG Coherence in Patients with Type 1 Diabetes. Diabetes Technol Ther. 2016 Mar;18(3):178-84. doi: 10.1089/dia.2015.0347. Epub 2016 Jan 8.

    PMID: 26745007DERIVED

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus

Interventions

InsulinConstriction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInvestigative Techniques

Study Officials

  • Anne-Sophie Sejling, MD

    Hillerod Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 18, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

DK(1)