Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

UNEEG medical

Status

Terminated

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: hyposafe H02

Study type

Interventional

Funder types

Industry

Identifiers

NCT02925676

Pilot 2 Diabetes

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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