Type 1 DiabetesNCT05495386
Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
A study testing Hyposafe hypoglycaemia notification device (H02) in people with Type 1 Diabetes, run by UNEEG Medical A/S.
Trial summary
This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hyposafe hypoglycaemia notification device (H02)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Type 1 diabetes diagnosed at least five years prior to inclusion in the study
- Age 18-70 years
- Impaired awareness, i.e., defined as unaware by the Pedersen-Bjergaard scale and history of at least one severe hypoglycaemia within the preceding year
- Use of continuous glucose monitoring at study start
Who cannot join
- High risk of surgical complications
- Involved in therapies with medical devices that deliver electrical energy into the area around the implant
- Infection at the site of device implantation
- Contraindications to the local anaesthetic used during implantation and explantation
- Have cochlear implant(s)
- Subject is scheduled to undergo MRI scan, ultrasound, radiation, or electrical current induced close to the implant, within 6 months after enrolment
Show all 9Show fewer
- Severe cardiac disease
- History of stroke/ cerebral haemorrhage and any other structural cerebral disease
- Active cancer or cancer diagnosis within the past 5 years
About this study
Official title: Investigation of Hypoglycaemia-induced EEG Changes in Participants With Type 1 Diabetes by Use of the Hyposafe H02 Device
This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed.
Read the detailed description
H02 is an implantable continuous EEG recorder that consists of an implant and an external device. The H02 system is based on a subcutaneous EEG measurement and acquisition of the EEG signal from the implant.
Participant will have the implantable part of H02 implanted under local anaesthesia. After a healing period, the participants will start using the external part of H02. They will wear the external part of H02 as much as possible both during daytime and night-time. The participant will use their own continuous glucose monitoring (CGM) during the study as normal practice. The participants will be exposed to insulin-induced hypoglycaemia once during the study.
- Conditions
- Type 1 Diabetes
- Being tested
- Hyposafe hypoglycaemia notification device (H02)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyposafe hypoglycaemia notification device (H02)Device
Also called H02
The H02 device consists of two parts:
- An implantable part which records the EEG signal and transmits the signal wirelessly to the external device.
- The external device receiving signals and storing data from the implant.
| Study group | Role | What they receive |
|---|---|---|
| Hyposafe H02 Device | Experimental | Hyposafe H02 Device will be used in the study Receives: Device: Hyposafe hypoglycaemia notification device (H02) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm.
Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant.
Measured: 7-8 months
To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.
Number SMBG measurements below 3 mmol/L glucose per participant
Measured: 7-8 months
To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.
Number of CGM values below 3 mmol/L glucose per participant
Measured: 7-8 months
Secondary outcomes (3)
To evaluate the safety of H02 in participants with type 1 diabetes.
- Number of adverse events 29 weeks after implantation (from visit 3 to visit 14)
- Number of adverse device effects (ADEs) 29 weeks after implantation (from visit 3 to visit 14)
Measured: 7-8 months
To evaluate the performance of H02 in participants with type 1 diabetes.
Number of device deficiencies (from visit 3 to visit 13)
Measured: 7-8 months
To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes.
Surgeon satisfaction will be evaluated by questionnaires after the implantation at visit 3 and after explantation at visit 13 of the implantable part of Hyposafe H02 Device
Measured: 0 and 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Withdrawn due to company interest and development of alternative devices for epilepsy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 0 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
- NCT05495386
- Sponsor's protocol ID
- U010
- Status last verified
- Dec 2023
- First submitted
- 24 May 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Hypoglycaemia-induced EEG Changes in Participants With Type 1 Diabetes by Use of the Hyposafe H02 Device
- ClinicalTrials.gov ID
- NCT05495386
- Acronym / sponsor ID
- U010
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to company interest and development of alternative devices for epilepsy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 10 Aug 2022 (actual)
- 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.
This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed.
Detailed description
H02 is an implantable continuous EEG recorder that consists of an implant and an external device. The H02 system is based on a subcutaneous EEG measurement and acquisition of the EEG signal from the implant.
Participant will have the implantable part of H02 implanted under local anaesthesia. After a healing period, the participants will start using the external part of H02. They will wear the external part of H02 as much as possible both during daytime and night-time. The participant will use their own continuous glucose monitoring (CGM) during the study as normal practice. The participants will be exposed to insulin-induced hypoglycaemia once during the study.
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 Device | Experimental | Device: Hyposafe hypoglycaemia notification device (H02)Hyposafe H02 Device will be used in the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Type 1 diabetes diagnosed at least five years prior to inclusion in the study
- Age 18-70 years
- Impaired awareness, i.e., defined as unaware by the Pedersen-Bjergaard scale and history of at least one severe hypoglycaemia within the preceding year
- Use of continuous glucose monitoring at study start
Key exclusion criteria (9 listed)
- High risk of surgical complications
- Involved in therapies with medical devices that deliver electrical energy into the area around the implant
- Infection at the site of device implantation
- Contraindications to the local anaesthetic used during implantation and explantation
- Have cochlear implant(s)
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 hypoglycaemia notification device (H02)Also: H02The H02 device consists of two parts: 1. An implantable part which records the EEG signal and transmits the signal wirelessly to the external device. 2. The external device receiving signals and storing data from the implant. | Device | Hyposafe H02 Device |
Primary outcome
To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm.
Time frame: 7-8 months
Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant.
To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.
Time frame: 7-8 months
Number SMBG measurements below 3 mmol/L glucose per participant
To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.
Time frame: 7-8 months
Number of CGM values below 3 mmol/L glucose per participant
3 secondary outcomes
To evaluate the safety of H02 in participants with type 1 diabetes.
Time frame: 7-8 months
To evaluate the performance of H02 in participants with type 1 diabetes.
Time frame: 7-8 months
To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes.
Time frame: 0 and 7-8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Hyposafe hypoglycaemia notification device (H02) in people with Type 1 Diabetes, run by UNEEG Medical A/S.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm. (time frame: 7-8 months). The study lists 3 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 22 Dec 2023.