HypoglycemiaPilotNCT01238016
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
A study testing experimental in people with Hypoglycemia, run by UNEEG Medical A/S at 1 site in Denmark.
Trial summary
The trial aims at measuring the safety and performance of the Hyposafe device. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy control subjects or and
- Male and female patient with type 1 diabetes for at least one year
- Age 18-70 years
- Impaired awareness of hypoglycaemia as defined by
- A score of ≥4 on the Gold-scale or
- Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month
- Multiple injection insulin therapy or continuous insulin injection therapy
- For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period
Who cannot join
- Severe cardiac disease
- History of myocardial infarction
- Cardiac arrhythmia
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- Active cancer or cancer diagnosis within the past five years
- Uremia defined as s-creatinine above 3 times upper reference value
Show all 23Show fewer
- Liver disease defined as s-ALAT above 3 times upper reference interval
- Inability to understand the informed consent
- Epilepsy
- Use of antiepileptic drugs for any purposes
- Clinical important hearing impairment
- Use of active implantable medical device including
- Pacemaker and ICD-unit
- 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)
- Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
- Infection at the site of device-implantation
- Any hemorrhagic disease
- Diving (snorkel diving allowed) or parachute jumping
- Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study
The trial aims at measuring the safety and performance of the Hyposafe device.
Read the detailed description
Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.
- Conditions
- Hypoglycemia
- Being tested
- experimental
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalDevice
| Study group | Role | What they receive |
|---|---|---|
| device | Other | Device implant and EEG recording Receives: Device: experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance
Measured: End of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2013
- Study completionAug 2014
Why it stopped: Replaced by new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNEEG Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238016
- Sponsor's protocol ID
- H01A03
- Acronym
- Pilot
- Status last verified
- Aug 2016
- First submitted
- 8 Nov 2010
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study
- ClinicalTrials.gov ID
- NCT01238016
- Acronym / sponsor ID
- Pilot / H01A03
- Conditions
- Hypoglycemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Replaced by new study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial aims at measuring the safety and performance of the Hyposafe device.
Detailed description
Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| device | Other | Device: experimentalDevice implant and EEG recording |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy control subjects or and
- Male and female patient with type 1 diabetes for at least one year
- Age 18-70 years
- Impaired awareness of hypoglycaemia as defined by
- Multiple injection insulin therapy or continuous insulin injection therapy
Key exclusion criteria (23 listed)
- Severe cardiac disease
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- Active cancer or cancer diagnosis within the past five years
- Uremia defined as s-creatinine above 3 times upper reference value
- Liver disease defined as s-ALAT above 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 |
|---|---|---|
| experimental | Device | device |
Primary outcome
Device performance
Time frame: End of observation
Results and safety
The study was stopped early (reason given: Replaced by new study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental in people with Hypoglycemia, run by UNEEG Medical A/S at 1 site 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 8 inclusion and 23 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 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Replaced by new study). Results are not available in the source record.
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?
Device performance (time frame: End of observation). 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 17 Aug 2016.