Trial Outcomes & Findings for Evaluation of the Hypoglycaemia Notification Device Hyposafe H02 (NCT NCT02925676)

NCT ID: NCT02925676

Last Updated: 2024-07-26

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-07-26

Participant Flow

Participant milestones

Measure	Hyposafe H02 All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Hyposafe H02 All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Baseline characteristics by cohort

Measure	Overall Study: Hyposafe H02 n=8 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Age, Continuous	57.5 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants
Region of Enrollment Denmark	8 participants n=5 Participants
Dieabetes duration	35 years STANDARD_DEVIATION 16.1 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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).

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Sensitivity Sensitivity (day)	100 Percentage
Sensitivity Sensitivity (night)	100 Percentage

PRIMARY outcome

Timeframe: 3 months

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).

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Positive Predictive Value Positive predictive value (day)	8 Percentage
Positive Predictive Value Positive predictive value (night)	2 Percentage

SECONDARY outcome

Timeframe: 3 months

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).

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Overall Sensitivity	81 Percentage

SECONDARY outcome

Timeframe: 3 months

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).

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Overall Positive Predictive Value	11 Percentage

SECONDARY outcome

Timeframe: 2 days

Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes.

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Sensitivity During Insulin-induced Hypoglycaemia	57 Percentage

SECONDARY outcome

Timeframe: 2 days

Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Positive Predictive Value for Insulin-induced Hypoglycaemia	100 Percentage

SECONDARY outcome

Timeframe: start up and after 3 months

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.

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Number of Participants With a Satisfactory EEG Quality Test	7 Participants

SECONDARY outcome

Timeframe: start up and after 3 months

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.

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Change in Impedance (kOhm) Over Time	7 Participants

SECONDARY outcome

Timeframe: 4 months

Total number of device deficiencies

Outcome measures

Measure	Overall Study: Hyposafe H02 n=8 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Device Deficiencies	15 Counts

SECONDARY outcome

Timeframe: 3 months

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)

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Mean Glucose Level at the Time of a Hypoglycaemia Notification Spontanous episodes	2.4 mmol/L glucose Interval 1.9 to 3.8
Mean Glucose Level at the Time of a Hypoglycaemia Notification Insulin-induced episodes	2 mmol/L glucose Interval 1.7 to 2.6

SECONDARY outcome

Timeframe: 3 weeks, 7 weeks and 15 weeks after implantation (baseline)

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'.

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Development in Discomfort Over Time Based on Questionnaires 3 weeks after implantation	4.1 Score on a scale Interval 3.0 to 5.0
Development in Discomfort Over Time Based on Questionnaires 7 weeks after implantation	4.7 Score on a scale Interval 4.0 to 5.0
Development in Discomfort Over Time Based on Questionnaires 15 weeks after implantation	4.9 Score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 1 month

User satisfaction were evaluated as to whether the subjects wished to continue to use the device

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
User Satisfaction Based on Questionnaire Number of participants that would like to continue to use the device	2 Participants
User Satisfaction Based on Questionnaire Number of participants that would not like to continue to use the device	5 Participants

SECONDARY outcome

Timeframe: 3 months

Mean number of hours of use per device is measured as recording time of device

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Mean Number of Hours of Use Per Device Use per day	13.5 Hours Interval 11.5 to 15.9
Mean Number of Hours of Use Per Device Use per night	8.2 Hours Interval 6.8 to 11.0

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Overall Study: Hyposafe H02 n=7 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Response to Hypoglycaemia Notification Spontaneous hypoglycemic episodes	100 Percentage
Response to Hypoglycaemia Notification Insulin-induced hypoglycemic episodes	87.5 Percentage

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Overall Study: Hyposafe H02 n=5 Participants All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Alarm Fatigue Based on Questionnaire 95% sensitivity - 15 false notifications weekly	2 Participants
Alarm Fatigue Based on Questionnaire 90% sensitivity - 9 false notifications weekly	3 Participants

Adverse Events

Overall Study: Hyposafe H02

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overall Study: Hyposafe H02 n=8 participants at risk All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device
Skin and subcutaneous tissue disorders Skin infection	12.5% 1/8 • Number of events 2 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
General disorders Implant site pain	62.5% 5/8 • Number of events 8 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Ear and labyrinth disorders Ear pain	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Nervous system disorders Implant site hyperesthesia	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Endocrine disorders Hypoglycaemia	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Infections and infestations Thooth infection	12.5% 1/8 • Number of events 3 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Musculoskeletal and connective tissue disorders Dupuytren's contracture	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 2 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Infections and infestations Influenza	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011
Surgical and medical procedures Renal stone removal	12.5% 1/8 • Number of events 1 • Adverse event were collected in a period of 17 weeks for each participant The adverse events were defined according to ISO14155:2011

Additional Information

Clinical Research Associate

UNEEG medical

Phone: +45 25657550

Email: clinical@uneeg.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor extend the embargo with up to 90 days if filling a patent is wanted by the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER