Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: hyposafe H02

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark
    • North Zealand Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyposafe H02; All subjects included are assigned to hyposafe H02-testing	Device: hyposafe H02; hypoglycaemia notification device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Principal Investigator: Ulrik Pedersen-Bjergaard, MD, PhD, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2016
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: Pilot 2 Diabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The main findings of study will be submitted for publication in a peer reviewed journal or made publically available at www.clinicaltrials.gov