Home and School Visits Intervention for Children With DM TYPE 1

NCT ID: NCT02137174

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Home and school visits

Group Type ACTIVE_COMPARATOR

Home and school visits

Intervention Type OTHER

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role lead

Responsible Party

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Eli Hershkovitz

Head of Pediatric Endocrinology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Endocrinology Unit, Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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EH-diab013

Identifier Type: -

Identifier Source: org_study_id

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