Home and School Visits Intervention for Children With DM TYPE 1

Diabetes Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137174
• Other study ID #: EH-diab013
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 10, 2014
• Last updated: May 12, 2014
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Ben-Gurion University of the Negev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

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.

Locations

Country	Name	City	State
Israel	Pediatric Endocrinology Unit, Soroka Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBA1C		2 YEARS	No
Secondary	Number of DKA episodes		2 YEARS	No
Secondary	Number of Hospitalizations		2 years	Yes
Secondary	Hypoglycemia rate		2 years	Yes