Clinical trial NCT01337362: Recurrent Hypoglycaemia in Type 1 Diabetes
Official title: Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycaemia
Keywords: Diabetes
Hypoglycaemia
EEG
Thermography
Hypoglycaemia-associated autonomic failure
QTc interval
Hypoglycemic alarm device
Hormone response
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Rigshospitalet, Denmark
name: UNEEG Medical A/S
First posted: 2011-04-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Background:

Patients with type 1 diabetes are at risk of severe hypoglycaemia as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia (hypoglycaemia unawareness). The episodes are associated with impaired quality of life and can lead to permanent brain damage and death.

During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines. Repeated hypoglycaemic episodes result in down regulation of counter regulatory and symptomatic responses. It is not known whether a similar phenomenon is present for cerebral dysfunction as judged by EEG changes and cognitive function.

The purpose 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.

The methods:

The investigators will recruit two groups of patients: Patients with hypoglycemia awareness and patients with hypoglycaemic unawareness.

The patients are exposed to hypoglycaemia on two concomitant days while the investigators record EEG and perform cognitive tests. Skin temperature is assessed by the use of thermography. If the patient has hypoglycaemic unawareness a 4 week period follows where the glycaemic control is loosened to avoid hypoglycaemia episodes and the patients is then exposed to hypoglycaemia again.

The prospect:

It is the investigators hope that results can contribute to improved understanding of hypoglycaemic EEG changes and skin temperature changes. This could be of potential benefit for patients with hypoglycaemic unawareness.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: EEG
timeFrame: 2 years
Secondary outcomes:
measure: QTc interval
timeFrame: 2 years
measure: Skin temperature
timeFrame: 2 years
measure: Auditory evoked potentials
timeFrame: 2 years
measure: Cognitive function
timeFrame: 2 years
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Hillerod Hospital
Study officials:
affiliation: Hillerod Hospital
name: Anne-Sophie Sejling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.