Hypoglycaemia Clinical Trial
Official title:
Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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