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Slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyposafe H02 | Experimental | All subjects included are assigned to hyposafe H02-testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyposafe H02 | Device | hypoglycaemia notification device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Overall Positive Predictive Value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrik Pedersen-Bjergaard, MD, PhD | Nordsjaellands Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Zealand Hospital | Hillerød | Denmark | ||||
| Odense University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyposafe H02 | All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study: Hyposafe H02 | All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | Percentage | 3 months |
|
|
Adverse event were collected in a period of 17 weeks for each participant
The adverse events were defined according to ISO14155:2011
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study: Hyposafe H02 | All subjects included are assigned to hyposafe H02-testing hyposafe H02: hypoglycaemia notification device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Possible or probable related to device |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | UNEEG medical | +45 25657550 | clinical@uneeg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2021 | Dec 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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). |
| 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. | 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 | 2 days |
| 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. | 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. | start up and after 3 months |
| Device Deficiencies | Total number of device deficiencies | 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) | 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'. | 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 | 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 | 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 | 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. | 3 months |
| Odense |
| 5000 |
| Denmark |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dieabetes duration | Mean | Standard Deviation | years |
|
|
| Primary | 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). | Posted | Number | Percentage | 3 months |
|
|
|
| Secondary | 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). | Posted | Number | Percentage | 3 months |
|
|
|
| Secondary | 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). | Posted | Number | Percentage | 3 months |
|
|
|
| Secondary | 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. | Posted | Number | Percentage | 2 days |
|
|
|
| Secondary | 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 | Posted | Number | Percentage | 2 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | start up and after 3 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | start up and after 3 months |
|
|
|
| Secondary | Device Deficiencies | Total number of device deficiencies | Posted | Number | Counts | 4 months |
|
|
|
| Secondary | 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) | Posted | Mean | Full Range | mmol/L glucose | 3 months |
|
|
|
| Secondary | 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'. | Posted | Mean | Full Range | Score on a scale | 3 weeks, 7 weeks and 15 weeks after implantation (baseline) |
|
|
|
| Secondary | User Satisfaction Based on Questionnaire | User satisfaction were evaluated as to whether the subjects wished to continue to use the device | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Mean Number of Hours of Use Per Device | Mean number of hours of use per device is measured as recording time of device | Posted | Mean | Full Range | Hours | 3 months |
|
|
|
| Secondary | 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 | Posted | Number | Percentage | 3 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Possible or probable related to device |
|
| Implant site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Administration site conditions Possible or probable related to device |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment | Possible or probable related to device |
|
| Implant site hyperesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Possible or probable related to device |
|
| Hypoglycaemia | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment | Possible or probable related to device |
|
| Thooth infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Unlikely related to device |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Unlikely related to device |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Unlikely related to device |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Unlikely related to device |
|
| Renal stone removal | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment | Unlikely related to device |
|
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.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|