Clinical trial NCT02925676: Evaluation of the Hypoglycaemia Notification Device Hyposafe H02
Official title: Evaluation of the Hypoglycaemia Notification Device Hyposafe H02 - the Pilot 2 Study - in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Hypoglycaemia
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the technical performance of the hyposafe H02 during everyday activities and during insulin-induced hypoglycaemia, in addition to safety issues associated with the implantation and use of the hyposafe H02 in subjects with type 1 diabetes.

Detailed description: While a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements and hence it is unreliable as a hypoglycaemia notification. Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe hypoglycaemia. However, some find these devices troublesome to use and are annoyed by the inaccuracy of the measurements and even after short-term use the coverage in subgroups of patients is as low as 50% of the time. Thus, there is a medical need for a reliable hypoglycaemia notification which is easy and convenient to use and with high sensitivity and high rate of positive prediction.

This clinical investigation is designed to evaluate the sensitivity and the positive predictive value of the Hyposafe H02 in subjects with type 1 diabetes during everyday activities and during insulin-induced hypoglycaemia. In addition, the investigation provides information regarding safety and usability of the device. This to verify that the Hyposafe H02 works as intended in subjects with type 1 diabetes before proceeding with a larger study in subjects with type 1 diabetes.

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any study related activities
* Type 1 diabetes diagnosed at least five years prior to inclusion in the study
* Impaired awareness and/or history of at least one severe hypoglycaemia within the preceding year

Exclusion Criteria:

* Severe cardiac disease
* History of stroke or cerebral haemorrhage and any other structural cerebral disease
* Active cancer or cancer diagnosis within the past 5 years
* Uraemia defined as s-creatinine ≥ 3 times upper reference value
* Liver disease defined as s-ALAT ≥ 3 times upper reference interval
* Epilepsy
* Use of antiepileptic drugs for any indication
* Clinically important hearing impairment
* Use of active implantable medical device including pacemaker and ICD-unit and cochlear implant
* Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
* Contraindications to the local anaesthetic used during implantation
* Known or suspected abuse of alcohol or any other neuro-active substances
* Infection at the site of device implantation
* Any haemorrhagic disease
* Females of childbearing potential who are pregnant or intend to become pregnant or are not using adequate contraceptive methods throughout the study
* Performing extreme sport, including scuba diving (snorkel diving is allowed) or parachute jumping
* Incapable of understanding the subject information or unlikely to complete the study for any reason
* Operating MRI scanners
* Operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military)
* Working at broadcast stations for television or FM/DAB radio
* Use of CGM or FGM with visible glucose measurements and activated glucose notifications
* Involved in therapies with medical devices that deliver electrical energy into the area around the implant

Primary outcomes:
measure: Sensitivity
timeFrame: 3 months
measure: Positive Predictive Value
timeFrame: 3 months
Secondary outcomes:
measure: Overall Sensitivity
timeFrame: 3 months
measure: Overall Positive Predictive Value
timeFrame: 3 months
measure: Sensitivity During Insulin-induced Hypoglycaemia
timeFrame: 2 days
measure: Positive Predictive Value for Insulin-induced Hypoglycaemia
timeFrame: 2 days
measure: Number of Participants With a Satisfactory EEG Quality Test
timeFrame: start up and after 3 months
measure: Change in Impedance (kOhm) Over Time
timeFrame: start up and after 3 months
measure: Device Deficiencies
timeFrame: 4 months
measure: Mean Glucose Level at the Time of a Hypoglycaemia Notification
timeFrame: 3 months
measure: Development in Discomfort Over Time Based on Questionnaires
timeFrame: 3 weeks, 7 weeks and 15 weeks after implantation (baseline)
measure: User Satisfaction Based on Questionnaire
timeFrame: 1 month
measure: Mean Number of Hours of Use Per Device
timeFrame: 3 months
measure: Response to Hypoglycaemia Notification
timeFrame: 3 months
measure: Alarm Fatigue Based on Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: North Zealand Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Ulrik Pedersen-Bjergaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: