- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016457
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
November 18, 2009 updated by: Sheba Medical Center
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kineret Mazor-Aronovitch, MD
- Phone Number: 972-3-5305022
- Email: kineret@gmail.com
Study Contact Backup
- Name: Orit Pinhas-Hamiel, MD
- Phone Number: 972-3-5305015
- Email: Orit.Hamiel@sheba.health.gov.il
Study Locations
-
-
-
Ramat Gan, Israel
- Recruiting
- Sheba Medical Center
-
Contact:
- Kineret Mazor-Aronovitch
- Email: kineret@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Duration of diabetes for more than 6 months
- Use of insulin pump for more than 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1C
Time Frame: Start of study, after 3 months, after 6 months
|
Start of study, after 3 months, after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: Before and after connecting to sensor
|
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
|
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
|
During the first week of connecting to sensor and during the last week of connecting
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kineret Mazor-Aronovitch, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Anticipated)
August 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
November 18, 2009
First Submitted That Met QC Criteria
November 18, 2009
First Posted (Estimate)
November 19, 2009
Study Record Updates
Last Update Posted (Estimate)
November 19, 2009
Last Update Submitted That Met QC Criteria
November 18, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-07-4980-KMA-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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