Recurrent Hypoglycaemia in Type 1 Diabetes

NCT ID: NCT01337362

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Hypoglycaemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients with hypoglycemia awareness

Patients who have symptoms when the blood sugar level is low

Group Type: ACTIVE_COMPARATOR

Insulin clamp

Intervention Type: PROCEDURE

Patients will be exposed to low bloodsugar

patients with hypoglycaemic unawareness.

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

Group Type: EXPERIMENTAL

Insulin clamp

Intervention Type: PROCEDURE

Patients will be exposed to low bloodsugar

Interventions

Insulin clamp

Patients will be exposed to low bloodsugar

Intervention Type: PROCEDURE

Other Intervention Names

Insulin; clamp

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

UNEEG Medical A/S

INDUSTRY

Sponsor Role: collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anne-Sophie Sejling

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne-Sophie Sejling, MD

Role: PRINCIPAL_INVESTIGATOR

Hillerod Hospital

Locations

Hillerod Hospital

Hillerød, Hillerød, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 37369531 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26745007 (View on PubMed)

Other Identifiers

H-1-2011-024

Identifier Type: -

Identifier Source: org_study_id