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

This study is not yet open for participant recruitment.
Verified February 2012 by Assaf-Harofeh Medical Center
Sponsor:
Collaborators:
Soroka University Medical Center
Wolfson Medical Center
The Chaim Sheba Medical Center
Kaplan Medical Center
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01525784
First received: November 3, 2011
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Hypoglycemia
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • to examine prospectively frequency of hypoglycemia [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to assess the effect of rt-cgms on quality of life of children and parents [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To examine prosectively the effect of rt-cgms on glycemic control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to follow the effect of rt-cgms on hba1c and on bg average and complications


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rt-CGMS
Using Rt-CGMS, approved by ministry of health as part f clinical care
Control
Not approved or suggested for RtCGMS. Other acceptabl means of therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Age 1-18 years
  • Type 1 Diabetes Mellitus

Exclusion Criteria:

  • Refusal to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525784

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

Locations
Israel
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
Investigators
Principal Investigator: Marianna rachmiel, md Assaf Haroffeh Medical Center
  More Information

No publications provided

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
Study First Received: November 3, 2011
Last Updated: February 1, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Assaf-Harofeh Medical Center:
rtCGMS
glycemic control
type 1 diabetes mellitus
youth

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

ClinicalTrials.gov processed this record on May 19, 2013