Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Hypoglycaemia Notification Device Hyposafe H02 - the Pilot 2 Study - in Subjects With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: hyposafe H02


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyposafe H02<br>All subjects included are assigned to hyposafe H02-testing | Device: hyposafe H02<br>* hypoglycaemia notification device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | Proportion of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes | 3 months | 
| Positive predictive value | Proportion of validated spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02 | 3 months | 
| Number of adverse events |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall sensitivity | Overall proportion of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes | 3 months | 
| overall positive predictive value | Overall proportion of validated hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02 | 3 months | 
| sensitivity during insulin-induced hypoglycaemia | Proportion of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes | 2 days | 
| positive predictive value for insulin-induced hypoglycaemia | Proportion of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02 | 2 days | 
| Change in EEG quality (power in alpha frequency band) over time |  | start up and after 3 months | 
| Change in impedance (kOhm) over time |  | start up and after 3 months | 
| Device complaints | Number of device complaints | 4 months | 
| Mean glucose level at the time of a hypoglycaemia notification |  | 3 months | 
| Number of adverse device effects |  | 4 months | 
| Feasibility of using hyposafe H02 on a daily basis based on diary |  | 3.5 months | 
| Development in discomfort over time based on questionnaires |  | 3 months | 
| Link strength between the implant and the external device (Volt) |  | 3.5 months | 
| User satisfaction based on questionnaire |  | 1 month | 
| Mean number of hours of use per hyposafe H02 device |  | 3.5 months | 
| Percentage of correct key press in response to hypoglycaemia notification |  | 3 months | 
| Alarm fatigue based on interview |  | 3.5 months | 
| User experience in an everyday context based on interview |  | 3.5 months |