Home and School Visits Intervention for Children With DM TYPE 1

May 12, 2014 updated by: Eli Hershkovitz, Ben-Gurion University of the Negev

The Efficacy of Constructed Intervention by Home and School Visits on Glycemic Control in Children With Type I Diabetes

Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Pediatric Endocrinology Unit, Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HbA1c ≥ 8% at baseline, and diabetes duration of at least 7 months.

Exclusion Criteria:

  • Patients during honeymoon period
  • Patients and their parents who do not speak Hebrew or Arabic
  • Patients who were not under any educational system
  • Patients who had other severe chronic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Home and school visits
Other: Home and school visits
Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBA1C
Time Frame: 2 YEARS
2 YEARS

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of DKA episodes
Time Frame: 2 YEARS
2 YEARS
Number of Hospitalizations
Time Frame: 2 years
2 years
Hypoglycemia rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 10, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH-diab013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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