Affect of RT-CGMS as Part of Clinical Care in Type 1 Diabetes Mellitus Patients
Prospective Short and Long Term Follow up of Pediatric Diabetes Mellitus Patients Receiving RT-CGMS as Part of National Clinical Care
1 other identifier
observational
300
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 3, 2012
February 1, 2012
1.9 years
November 3, 2011
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to examine prospectively frequency of hypoglycemia
3 years
Secondary Outcomes (2)
to assess the effect of rt-cgms on quality of life of children and parents
3 years
To examine prosectively the effect of rt-cgms on glycemic control
3 years
Study Arms (2)
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
Eligibility Criteria
All patients recieving CGMS for treatment group and those without RTCGMS but all other management, for control group.
You may qualify if:
- Age 1-18 years
- Type 1 Diabetes Mellitus
You may not qualify if:
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assaf-Harofeh Medical Centerlead
- Soroka University Medical Centercollaborator
- Wolfson Medical Centercollaborator
- The Chaim Sheba Medical Centercollaborator
- Kaplan Medical Centercollaborator
Study Sites (4)
Soroka University Medical Center
Beersheba, Israel
Wolfson Medical Center
Holon, Israel
Sheba Medical Center
Tel Aviv, Israel
Assaf harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (1)
Rachmiel M, Landau Z, Boaz M, Mazor Aronovitch K, Loewenthal N, Ben-Ami M, Levy-Shraga Y, Modan-Moses D, Haim A, Abiri S, Pinhas-Hamiel O. The use of continuous glucose monitoring systems in a pediatric population with type 1 diabetes mellitus in real-life settings: the AWeSoMe Study Group experience. Acta Diabetol. 2015 Apr;52(2):323-9. doi: 10.1007/s00592-014-0643-6. Epub 2014 Sep 16.
PMID: 25223531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianna rachmiel, md
Assaf Haroffeh Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Marianna Rachmiel, Assaf Haroffeh Medical Center
Study Record Dates
First Submitted
November 3, 2011
First Posted
February 3, 2012
Study Start
February 1, 2012
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
February 3, 2012
Record last verified: 2012-02