Type 1 DiabetesHypo-SenseNCT02225379
Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia
A study testing Hypo-Sense (non invasive sensor) in people with Type 1 Diabetes and Nocturnal Hypoglycemia, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Nocturnal Hypoglycemia
- What is being tested?
- Hypo-Sense (non invasive sensor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Jul 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing an inform consent form prior to any trial related procedure
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Age > 18 years old
Who cannot join
- Participating in other device or drug study
- Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Chronic skin problem in the lower inner arm
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense Sensor as a Tool for Detection of Hypoglycemia - Exploratory Study for Prototype Rev 1
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device.
The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods
Read more
The proposed study will be consisting of two main segments:
The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer.
The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events.
During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events.
During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).
- Conditions
- Type 1 Diabetes, Nocturnal Hypoglycemia
- Being tested
- Hypo-Sense (non invasive sensor)
- Keywords
- Type 1 Diabetes, Hypoglycemia detection, Non-invasive sensor, Nocturnal hypoglycemia
- 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.
Hypo-Sense (non invasive sensor)Device
Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
| Study group | Role | What they receive |
|---|---|---|
| Hypo-Sense (non invasive sensor) | Experimental | Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced. Receives: Device: Hypo-Sense (non invasive sensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer
Measured: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Positive Predictive Value of the hypo-Sense
Positive Predictive Value of the hypo sense- the proportion of validated ("true") hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor
Measured: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Night Sense Ltd
- Responsible party
- Sponsor
- Investigators
- M Phillip, Prof, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225379
- Sponsor's protocol ID
- 029514ctil
- Acronym
- Hypo-Sense
- Status last verified
- Jan 2017
- First submitted
- 29 Jul 2014
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense Sensor as a Tool for Detection of Hypoglycemia - Exploratory Study for Prototype Rev 1
- ClinicalTrials.gov ID
- NCT02225379
- Acronym / sponsor ID
- Hypo-Sense / 029514ctil
- Conditions
- Type 1 Diabetes, Nocturnal Hypoglycemia
- Keywords
- Type 1 Diabetes, Hypoglycemia detection, Non-invasive sensor, Nocturnal hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Night Sense Ltd
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Aug 2014 (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.
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device.
The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods
The proposed study will be consisting of two main segments:
The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer.
The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events.
During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events.
During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypo-Sense (non invasive sensor) | Experimental | Device: Hypo-Sense (non invasive sensor)Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signing an inform consent form prior to any trial related procedure
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Age > 18 years old
Key exclusion criteria (5 listed)
- Participating in other device or drug study
- Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Chronic skin problem in the lower inner arm
- Pregnant or breast feeding women
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 |
|---|---|---|
| Hypo-Sense (non invasive sensor)Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. | Device | Hypo-Sense (non invasive sensor) |
Primary outcome
Sensitivity
Time frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer
Positive Predictive Value of the hypo-Sense
Time frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
Positive Predictive Value of the hypo sense- the proportion of validated ("true") hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
M Phillip, Prof principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypo-Sense (non invasive sensor) in people with Type 1 Diabetes and Nocturnal Hypoglycemia, run by Rabin Medical Center at 1 site in Israel.
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 5 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: finished, as of the sponsor's last update on 11 Jan 2017. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)). 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 11 Jan 2017.