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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
hypoglycaemia notification device
North Zealand Hospital
Hillerød, Denmark
Odense University Hospital
Odense, Denmark
Sensitivity
Number of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG).
Time frame: 3 months
Positive Predictive Value
Number of validated spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of notification from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG).
Time frame: 3 months
Overall Sensitivity
Total number of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).
Time frame: 3 months
Overall Positive Predictive Value
Total number of validated hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).
Time frame: 3 months
Sensitivity During Insulin-induced Hypoglycaemia
Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes.
Time frame: 2 days
Positive Predictive Value for Insulin-induced Hypoglycaemia
Number 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
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Number of Participants With a Satisfactory EEG Quality Test
The EEG quality test was performed twice in the study. At start up and at the end of the study. Evaluation was based on visual review of EEG of known phenomena and artefacts by an experienced EEG reviewer.
Time frame: start up and after 3 months
Change in Impedance (kOhm) Over Time
The EEG performance was measured as the impedance as a function of time. An impedance value below 5 kOhm is considered very good. Number of participants with impedance values below 5 kOhm and no change over time is reported.
Time frame: start up and after 3 months
Device Deficiencies
Total number of device deficiencies
Time frame: 4 months
Mean Glucose Level at the Time of a Hypoglycaemia Notification
Glucose levels were measured at the time of a hypoglycaemia notification during an outpatients settings (the spontaneous episodes) and during insulin-induced hypoglycaemia (the insulin-induced episodes)
Time frame: 3 months
Development in Discomfort Over Time Based on Questionnaires
Implant discomfort over time were evaluated at 3 time points; on average 3 weeks, 7 weeks and 15 weeks after implantation (baseline). Here the categories were converted into cardinal numbers: ranging from strongly agree=5 to strongly disagree=1 on the statement ''The implant has not caused discomfort in the past two days'.
Time frame: 3 weeks, 7 weeks and 15 weeks after implantation (baseline)
User Satisfaction Based on Questionnaire
User satisfaction were evaluated as to whether the subjects wished to continue to use the device
Time frame: 1 month
Mean Number of Hours of Use Per Device
Mean number of hours of use per device is measured as recording time of device
Time frame: 3 months
Response to Hypoglycaemia Notification
Response to hypoglyceamia notifications measured as the participants were able to take preventive actions upon notification of hypoglycaemia in an outpatient settings (the spontaneous hypoglycemic episodes) and during insulin-induced hypoglycaemia
Time frame: 3 months
Alarm Fatigue Based on Questionnaire
The participants were given a questionnaire regarding their preferences for sensitivity and false alarms at the end of the study. Reporting are for preferences during the day.
Time frame: 3 months