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NCT01382459 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01382459
Other study ID # sor517111ctil
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 23, 2011
Last updated June 24, 2011
Start date July 2011

Study information
Verified date June 2011
Source Soroka University Medical Center
Contact Eli Hershkovitz, PI
Phone 972- 522629025
Email elih@bgu.ac.il
Is FDA regulated No
Health authority Israel: Clalit Health Services
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Soroka medical center Beer Sheva

Sponsors (2)
Lead Sponsor Collaborator
Soroka University Medical Center Clalit Health Services

Country where clinical trial is conducted

Israel, 

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