Type I DiabetesNCT00361608
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
An observational study of Type I Diabetes, run by EarlySense Ltd. at 1 site in Israel.
Trial summary
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- EarlySense ES 16
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to May 2009
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diabetes I
Who may be able to join
- Age between 12-18 years
- Diagnosis of type I diabetes for at least a year
- Home close to participating center
- Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.
Who cannot join
- Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
- Any other pre-existing medical pathology unrelated to diabetes.
- Inability of the patient or his guardian to use the Guardian RT.
Trial locations and contacts
1 site in 1 country.
About this study
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.
Read the detailed description
The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days.
During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:
- glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
- glucose levels tested by SBGM -Self Blood Glucose Measurement.
These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.
- Conditions
- Type I Diabetes
- Being tested
- EarlySense ES 16
- Keywords
- diabetes, hypoglycemia, monitor, children with Type I Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlySense ES 16Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJul 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schneider Children's Medical Center, Israel
- Responsible party
- Sponsor
- Investigators
- Liat de Vries, M.D., Principal investigator, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361608
- Sponsor's protocol ID
- ES-CI 03
- Other IDs
- 4006
- Status last verified
- Apr 2008
- First submitted
- 6 Aug 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
- ClinicalTrials.gov ID
- NCT00361608
- Acronym / sponsor ID
- ES-CI 03
- Conditions
- Type I Diabetes
- Keywords
- diabetes, hypoglycemia, monitor, children with Type I Diabetes
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Schneider Children's Medical Center, Israel
- Study start
- Jul 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Aug 2006 (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.
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.
Detailed description
The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days.
During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:
- glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
- glucose levels tested by SBGM -Self Blood Glucose Measurement.
These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diabetes I
Key inclusion criteria (4 listed)
- Age between 12-18 years
- Diagnosis of type I diabetes for at least a year
- Home close to participating center
- Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.
Key exclusion criteria (3 listed)
- Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
- Any other pre-existing medical pathology unrelated to diabetes.
- Inability of the patient or his guardian to use the Guardian RT.
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 |
|---|---|---|
| EarlySense ES 16 | Device | – |
Primary outcome
Not reported in the source record.
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 19 Jul 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.
Liat de Vries, M.D. principal investigator
Schneider Children's Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes, run by EarlySense Ltd. 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 4 inclusion and 3 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 19 Jul 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 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 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.
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 19 Jul 2016.