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Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382459
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clalit Health Services
Information provided by:
Soroka University Medical Center
  Purpose
The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.

Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 100
Study Start Date: July 2011
Groups/Cohorts
type 1 DM children- intervention group
will have home visits and trainings at school
type 1 DM children- control group
will receive the standard care at the clinic

Detailed Description:

The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:

  • A decrease in HbA1C levels.
  • A decrease in Hypoglycemia events.
  • A decrease in DKA events.
  • A decrease in patients' visits in ER and hospitalizations.
  • An improvement in the knowledge of the patients and their families about the disease.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.
Criteria

Inclusion Criteria:

  • Type 1 DM diagnosis from at least 8 months/
  • HbA1C levels >8
  • Signed inform consent.

Exclusion Criteria:

- Children who are not in educational settings and are not hebrew or arabic speakers.

  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): NCT01382459


Contacts
Contact: Eli Hershkovitz, PI 972- 522629025 elih@bgu.ac.il
Contact: Addi Maabari, S.C 972-547280902 adimaa@clalit.org.il

Locations
Israel
Soroka medical center Not yet recruiting
Beer Sheva, Israel
Contact: Eli Hershkovitz, PI    972-522629025    elih@bgu.ac.il   
Sponsors and Collaborators
Soroka University Medical Center
Clalit Health Services
  More Information

Responsible Party: Prof. Eli Hershkovitz, Pediatric endocrinology and diabetes unit
ClinicalTrials.gov Identifier: NCT01382459     History of Changes
Other Study ID Numbers: sor517111ctil
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Soroka University Medical Center:
children

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