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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01016457
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Before and after connecting to sensor ] [ Designated as safety issue: No ]
  • Number of night hypoglycemias [ Time Frame: During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting ] [ Designated as safety issue: Yes ]
  • Mean glucose level [ Time Frame: During the first week of connecting to sensor and during the last week of connecting ] [ Designated as safety issue: Yes ]

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
  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on October 21, 2014