NCT01382459

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

First QC Date

June 23, 2011

Last Update Submit

June 24, 2011

Conditions

Keywords

children

Study Arms (2)

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

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka medical center

Beersheba, Israel, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Eli Hershkovitz, PI

CONTACT

Addi Maabari, S.C

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

July 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations