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Affect of RT-CGMS as Part of Clinical Care in Type 1 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT01525784
Recruitment Status : Unknown
Verified February 2012 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2012
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy.Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .

The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the investigators study is to examine prospectively the short and long term effect of the RT-CGMS routine usage, in daily routine life of the diabetic child.

Condition or disease
Hypoglycemia Type 1 Diabetes Mellitus

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Short and Long Term Follow up of Pediatric Diabetes Mellitus Patients Receiving RT-CGMS as Part of National Clinical Care
Study Start Date : February 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Using Rt-CGMS, approved by ministry of health as part f clinical care
Not approved or suggested for RtCGMS. Other acceptabl means of therapy

Outcome Measures

Primary Outcome Measures :
  1. to examine prospectively frequency of hypoglycemia [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. to assess the effect of rt-cgms on quality of life of children and parents [ Time Frame: 3 years ]
  2. To examine prosectively the effect of rt-cgms on glycemic control [ Time Frame: 3 years ]
    to follow the effect of rt-cgms on hba1c and on bg average and complications

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients recieving CGMS for treatment group and those without RTCGMS but all other management, for control group.

Inclusion Criteria:

  • Age 1-18 years
  • Type 1 Diabetes Mellitus

Exclusion Criteria:

  • Refusal to participate
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): NCT01525784

Contact: Marianna Rachmiel, MD 972-8-9779133 mariannar@asaf.health.gov.il

Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel
Contact: Nta Lebental         
Wolfson Medical Center Not yet recruiting
Holon, Israel
Contact: Zohar Landau, MD         
Sheba Medical Center Not yet recruiting
TEl Aviv, Israel
Contact: Orit Hamiel, MD         
Assaf harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Marianna Rachmiel, MD       mariannar@asaf.health.gov.il   
Principal Investigator: Marianna rachmiel, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Soroka University Medical Center
Wolfson Medical Center
The Chaim Sheba Medical Center
Kaplan Medical Center
Principal Investigator: Marianna rachmiel, md Assaf Haroffeh Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assaf Harofeh MC, Dr. Marianna Rachmiel, Assaf Haroffeh Medical Center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01525784     History of Changes
Other Study ID Numbers: 88\11
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
glycemic control
type 1 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