Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

NCT01178476 | Withdrawn DMC

• 1 other identifier: Hyposafe-hypo-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic control, which in turn leads to increased diabetes related morbidity and mortality. Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with characteristic changes in EEG with a decrease in alpha activity and an increase in delta and theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can be recorded from subcutaneously placed electrodes using an automated mathematical algorithm based on non-linear spectral analysis. Experimental findings hold promises that an alarm, given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by ingestion of carbohydrate. This is the first larger scale trial testing the clinical applicability of a hypoglycaemia-alarm based on real-time analysis of EEG-signals.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• The frequency of severe hypoglycaemia event

  six months

Secondary Outcomes (1)

• The frequency of clinical hypoglycaemia (sensation of hypoglycaemia and BG<3.5mmol/l), biochemical hypoglycaemia (BG<3.5mmol/l), and nocturnal hypoglycaemia (waking up with a sensation of hypoglycaemia and BG<3.5mmol/l)

  six months

Study Arms (2)

Hyposafe Hypoglycemia alarm device

EXPERIMENTAL

EEG based hypoglycemia detection

Device: Hyposafe Hypoglycaemia alarm device

Regular glucose control

ACTIVE COMPARATOR

Regular glucose control group

Device: Hyposafe Hypoglycaemia alarm device

Interventions

Hyposafe Hypoglycaemia alarm device DEVICE

An EEG based hypoglycemia alarm is tested against standard glucose measurement on the risk of severe hypoglycemia

Hyposafe Hypoglycemia alarm device; Regular glucose control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patient with type 1 diabetes for at least one year
• Age 18-70 years
• Impaired awareness of hypoglycaemia as defined by
• A score of ≥4 on the Gold-scale (Appendix 8) or
• Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month
• Multiple injection insulin therapy or continuous insulin injection therapy
• For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period

You may not qualify if:

• Severe cardiac disease
• History of myocardial infarction
• Cardiac arrhythmia
• Previous stroke or cerebral haemorrhage and any other structural cerebral disease
• Active cancer or cancer diagnosis within the past five years
• Uremia defined as s-creatinine above 3 times upper reference value
• Liver disease defined as s-ALAT above 3 times upper reference interval
• Inability to understand the informed consent
• Epilepsy
• Use of antiepileptic drugs for any purposes
• Clinical important hearing impairment
• Use of active implantable medical device including
• Pacemaker and ICD-unit
• Cochlear implant
• Use of following drugs

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (1)

Hillerød Sygehus

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Birger Thorsteinsson, MD.

  Medical Department, Hillerød Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: August 10, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 10, 2014

Record last verified: 2010-08

Locations

DK (1)