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Recurrent Hypoglycaemia in Type 1 Diabetes

Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01337362
Acronym
HypoNeuro
Enrollment
23
Registered
2011-04-18
Start date
2011-05-31
Completion date
2013-06-30
Last updated
2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycaemia

Keywords

Diabetes, Hypoglycaemia, EEG, Thermography, Hypoglycaemia-associated autonomic failure, QTc interval, Hypoglycemic alarm device, Hormone response

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.

Interventions

PROCEDUREInsulin clamp

Patients will be exposed to low bloodsugar

Sponsors

University of Southern Denmark
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
UNEEG Medical A/S
CollaboratorINDUSTRY
Hillerod Hospital, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EEG2 yearsEEG 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.

Secondary

MeasureTime frameDescription
QTc interval2 yearsThe investigators want to investigate whether the QTc complex gets wider during hypoglycaemia. This is in order to see whether long QTc could be the explanation behind sudden dearth in diabetes patients.
Skin temperature2 yearsSkin temperature will be measured by thermography. The investigators want to see whether the skin can be used as a biomarker for hypoglycaemia.
Auditory evoked potentials2 yearsThe investigators what to see whether there is any difference in auditory evoked potentials (AEP) between aware and unaware diabetic patients. The subject will hear a common and a rare sound in a 4:1 ratio while the EEG is recorded. Afterwards the data is analyzed and the AEPs are addressed.
Cognitive function2 yearsThe investigators want to address whether there are any differences in the cognitive function between aware and unaware patients. The cognitive function will be addressed by the use of cognitive function tests (CalCAP) and Stroops tests as well.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026