NCT02137174

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 10, 2014

Last Update Submit

May 12, 2014

Conditions

Diabetes Type 1

Outcome Measures

Primary Outcomes (1)

  • HBA1C

    2 YEARS

Secondary Outcomes (3)

  • Number of DKA episodes

    2 YEARS

  • Number of Hospitalizations

    2 years

  • Hypoglycemia rate

    2 years

Study Arms (2)

Home and school visits

ACTIVE COMPARATOR
Other: Home and school visits

Control

NO INTERVENTION

Interventions

Home and school visitsOTHER

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.

Home and school visits

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Endocrinology Unit, Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Endocrinology Unit

Study Record Dates

First Submitted

May 10, 2014

First Posted

May 13, 2014

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

February 1, 2014

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

IL(1)