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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Rigshospitalet, Denmark | OTHER |
| UNEEG Medical A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hypoglycemia awareness | Active Comparator | Patients who have symptoms when the blood sugar level is low |
|
| patients with hypoglycaemic unawareness. | Experimental | Patients who do not feel any symptoms when the blood sugar levels are low |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin clamp | Procedure | Patients will be exposed to low bloodsugar |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval | The 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. | 2 years |
| Skin temperature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie Sejling, MD | Hillerod Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillerod Hospital | Hillerød | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37369531 | Derived | 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. | |
| 26745007 | Derived |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D003250 | Constriction |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Skin temperature will be measured by thermography. The investigators want to see whether the skin can be used as a biomarker for hypoglycaemia.
| 2 years |
| Auditory evoked potentials | The 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. | 2 years |
| Cognitive function | The 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. | 2 years |
| 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. |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008919 | Investigative Techniques |