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

NCT01525784 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2012-02-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Soroka University Medical Center

    collaborator OTHER

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • The Chaim Sheba Medical Center

    collaborator OTHER

  • Kaplan Medical Center

    collaborator OTHER

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Marianna rachmiel, md · Assaf Haroffeh Medical Center

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525784 on ClinicalTrials.gov