Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02925676
• Other study ID #: Pilot 2 Diabetes
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2016
• Est. completion date: September 10, 2018

Study information

• Verified date: March 2021
• Source: UNEEG Medical A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 10, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Device:
• hyposafe H02
hypoglycaemia notification device

Locations

Country	Name	City	State
Denmark	North Zealand Hospital	Hillerød
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
UNEEG Medical A/S

Country where clinical trial is conducted

Denmark, 

Outcome

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