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Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01016457
Recruitment Status : Unknown
Verified November 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : November 19, 2009
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Guardian RT Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Study Start Date : December 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Guardian RT
    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.
    Other Name: Real-time continuous glucose monitoring

Outcome Measures

Primary Outcome Measures :
  1. HbA1C [ Time Frame: Start of study, after 3 months, after 6 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Before and after connecting to sensor ]
  2. Number of night hypoglycemias [ Time Frame: During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting ]
  3. Mean glucose level [ Time Frame: During the first week of connecting to sensor and during the last week of connecting ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Duration of diabetes for more than 6 months
  • Use of insulin pump for more than 3 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016457


Contacts
Contact: Kineret Mazor-Aronovitch, MD 972-3-5305022 kineret@gmail.com
Contact: Orit Pinhas-Hamiel, MD 972-3-5305015 Orit.Hamiel@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Kineret Mazor-Aronovitch       kineret@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Kineret Mazor-Aronovitch, MD
More Information

Responsible Party: Dr. Kineret Mazor-Aronovitch, Ped Endocrine & Diabetes Unit, Safra's Children Hospital, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01016457     History of Changes
Other Study ID Numbers: SHEBA-07-4980-KMA-CTIL
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Sheba Medical Center:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases