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

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. Identifier: NCT01382459
Recruitment Status : Unknown
Verified June 2011 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Clalit Health Services
Information provided by:
Soroka University Medical Center

Brief Summary:
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 or disease
Type 1 Diabetes Mellitus

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.

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

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.

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.

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 identifier (NCT number): NCT01382459

Contact: Eli Hershkovitz, PI 972- 522629025
Contact: Addi Maabari, S.C 972-547280902

Soroka medical center Not yet recruiting
Beer Sheva, Israel
Contact: Eli Hershkovitz, PI    972-522629025   
Sponsors and Collaborators
Soroka University Medical Center
Clalit Health Services

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

Keywords provided by Soroka University Medical Center:

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