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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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 Intervention Phase
Diabetes Mellitus Device: Guardian RT Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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

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

Inclusion Criteria:

  • Duration of diabetes for more than 6 months
  • Use of insulin pump for more than 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01016457

Contact: Kineret Mazor-Aronovitch, MD 972-3-5305022
Contact: Orit Pinhas-Hamiel, MD 972-3-5305015

Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Kineret Mazor-Aronovitch   
Sponsors and Collaborators
Sheba Medical Center
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 Identifier: NCT01016457     History of Changes
Other Study ID Numbers: SHEBA-07-4980-KMA-CTIL
Study First Received: November 18, 2009
Last Updated: November 18, 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 processed this record on September 19, 2017