Back to resultsEvaluation of the Hypoglycaemia Notification Device Hyposafe H02
Primary Purpose
Diabetes Mellitus, Type 1
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
hyposafe H02
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1
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
Sites / Locations
- North Zealand Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hyposafe H02
Arm Description
All subjects included are assigned to hyposafe H02-testing
Outcomes
Primary Outcome Measures
sensitivity
Proportion of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes
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
Number of adverse events
Secondary Outcome Measures
overall sensitivity
Overall proportion of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes
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
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
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
Change in EEG quality (power in alpha frequency band) over time
Change in impedance (kOhm) over time
Device complaints
Number of device complaints
Mean glucose level at the time of a hypoglycaemia notification
Number of adverse device effects
Feasibility of using hyposafe H02 on a daily basis based on diary
Development in discomfort over time based on questionnaires
Link strength between the implant and the external device (Volt)
User satisfaction based on questionnaire
Mean number of hours of use per hyposafe H02 device
Percentage of correct key press in response to hypoglycaemia notification
Alarm fatigue based on interview
User experience in an everyday context based on interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02925676
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
October 5, 2016 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNEEG Medical A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyposafe H02
Arm Type
Experimental
Arm Description
All subjects included are assigned to hyposafe H02-testing
Intervention Type
Device
Intervention Name(s)
hyposafe H02
Intervention Description
hypoglycaemia notification device
Primary Outcome Measure Information:
Title
sensitivity
Description
Proportion of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes
Time Frame
3 months
Title
Positive predictive value
Description
Proportion of validated spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02
Time Frame
3 months
Title
Number of adverse events
Time Frame
4 months
Secondary Outcome Measure Information:
Title
overall sensitivity
Description
Overall proportion of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes
Time Frame
3 months
Title
overall positive predictive value
Description
Overall proportion of validated hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02
Time Frame
3 months
Title
sensitivity during insulin-induced hypoglycaemia
Description
Proportion of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes
Time Frame
2 days
Title
positive predictive value for insulin-induced hypoglycaemia
Description
Proportion of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02
Time Frame
2 days
Title
Change in EEG quality (power in alpha frequency band) over time
Time Frame
start up and after 3 months
Title
Change in impedance (kOhm) over time
Time Frame
start up and after 3 months
Title
Device complaints
Description
Number of device complaints
Time Frame
4 months
Title
Mean glucose level at the time of a hypoglycaemia notification
Time Frame
3 months
Title
Number of adverse device effects
Time Frame
4 months
Title
Feasibility of using hyposafe H02 on a daily basis based on diary
Time Frame
3.5 months
Title
Development in discomfort over time based on questionnaires
Time Frame
3 months
Title
Link strength between the implant and the external device (Volt)
Time Frame
3.5 months
Title
User satisfaction based on questionnaire
Time Frame
1 month
Title
Mean number of hours of use per hyposafe H02 device
Time Frame
3.5 months
Title
Percentage of correct key press in response to hypoglycaemia notification
Time Frame
3 months
Title
Alarm fatigue based on interview
Time Frame
3.5 months
Title
User experience in an everyday context based on interview
Time Frame
3.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Pedersen-Bjergaard, MD, PhD
Organizational Affiliation
Nordsjaellands Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Zealand Hospital
City
Hillerød
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Evaluation of the Hypoglycaemia Notification Device Hyposafe H02
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