Diabetes Mellitus, Type 1NCT02925676
Evaluation of the Hypoglycaemia Notification Device Hyposafe H02
A study testing hyposafe H02 in people with Diabetes Mellitus, Type 1, run by UNEEG Medical A/S at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- hyposafe H02
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Oct 2016to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
North Zealand Hospital
Hillerød
Odense University Hospital
Odense, 5000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- hyposafe H02
- Keywords
- Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyposafe H02Device
hypoglycaemia notification device
| Study group | Role | What they receive |
|---|---|---|
| hyposafe H02 | Experimental | All subjects included are assigned to hyposafe H02-testing Receives: Device: hyposafe H02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 3 months
Secondary outcomes (13)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: start up and after 3 months
Device Deficiencies
Total number of device deficiencies
Measured: 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)
Measured: 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'.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start5 Oct 2016
- Primary completion29 Aug 2018
- Study completion10 Sep 2018
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNEEG Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrik Pedersen-Bjergaard, MD, PhD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925676
- Sponsor's protocol ID
- Pilot 2 Diabetes
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2016
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hypoglycaemia Notification Device Hyposafe H02 - the Pilot 2 Study - in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02925676
- Acronym / sponsor ID
- Pilot 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyposafe H02 | Experimental | Device: hyposafe H02All subjects included are assigned to hyposafe H02-testing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyposafe H02hypoglycaemia notification device | Device | hyposafe H02 |
Primary outcome
Sensitivity
Time frame: 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).
Positive Predictive Value
Time frame: 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).
13 secondary outcomes
Overall Sensitivity
Time frame: 3 months
Overall Positive Predictive Value
Time frame: 3 months
Sensitivity During Insulin-induced Hypoglycaemia
Time frame: 2 days
Positive Predictive Value for Insulin-induced Hypoglycaemia
Time frame: 2 days
Number of Participants With a Satisfactory EEG Quality Test
Time frame: start up and after 3 months
Change in Impedance (kOhm) Over Time
Time frame: start up and after 3 months
Device Deficiencies
Time frame: 4 months
Mean Glucose Level at the Time of a Hypoglycaemia Notification
Time frame: 3 months
Development in Discomfort Over Time Based on Questionnaires
Time frame: 3 weeks, 7 weeks and 15 weeks after implantation (baseline)
User Satisfaction Based on Questionnaire
Time frame: 1 month
Mean Number of Hours of Use Per Device
Time frame: 3 months
Response to Hypoglycaemia Notification
Time frame: 3 months
Alarm Fatigue Based on Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Pedersen-Bjergaard, MD, PhD principal investigator
Nordsjaellands Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyposafe H02 in people with Diabetes Mellitus, Type 1, run by UNEEG Medical A/S at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.