Diabetes MellitusPhase 4NCT01016457
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
A Phase 4 study testing Guardian RT in people with Diabetes Mellitus, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Guardian RT
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 4
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Duration of diabetes for more than 6 months
- Use of insulin pump for more than 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Kineret Mazor-Aronovitch, kineret@gmail.com
About this study
The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.
- Conditions
- Diabetes Mellitus
- Being tested
- Guardian RT
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian RTDevice
Also called Real-time continuous glucose monitoring
The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: Start of study, after 3 months, after 6 months
Secondary outcomes (3)
Quality of life
Measured: Before and after connecting to sensor
Number of night hypoglycemias
Measured: During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting
Mean glucose level
Measured: During the first week of connecting to sensor and during the last week of connecting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Kineret Mazor-Aronovitch, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016457
- Sponsor's protocol ID
- SHEBA-07-4980-KMA-CTIL
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01016457
- Acronym / sponsor ID
- SHEBA-07-4980-KMA-CTIL
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Nov 2009 (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 purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Duration of diabetes for more than 6 months
- Use of insulin pump for more than 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Guardian RTAlso: Real-time continuous glucose monitoringThe sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits. | Device | – |
Primary outcome
HbA1C
Time frame: Start of study, after 3 months, after 6 months
3 secondary outcomes
Quality of life
Time frame: Before and after connecting to sensor
Number of night hypoglycemias
Time frame: During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting
Mean glucose level
Time frame: During the first week of connecting to sensor and during the last week of connecting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
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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.
Kineret Mazor-Aronovitch, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guardian RT in people with Diabetes Mellitus, run by Sheba 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Nov 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kineret Mazor-Aronovitch, MD (972-3-5305022, kineret@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: Start of study, after 3 months, after 6 months). 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 19 Nov 2009.