Back to resultsHome and School Visits Intervention for Children With DM TYPE 1
Primary Purpose
Diabetes Type 1
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Home and school visits
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Type 1
Eligibility Criteria
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
Sites / Locations
- Pediatric Endocrinology Unit, Soroka Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Home and school visits
Control
Arm Description
Outcomes
Primary Outcome Measures
HBA1C
Secondary Outcome Measures
Number of DKA episodes
Number of Hospitalizations
Hypoglycemia rate
Full Information
NCT ID
NCT02137174
First Posted
May 10, 2014
Last Updated
May 12, 2014
Sponsor
Ben-Gurion University of the Negev
1. Study Identification
Unique Protocol Identification Number
NCT02137174
Brief Title
Home and School Visits Intervention for Children With DM TYPE 1
Official Title
The Efficacy of Constructed Intervention by Home and School Visits on Glycemic Control in Children With Type I Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ben-Gurion University of the Negev
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home and school visits
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Home and school visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
HBA1C
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
Number of DKA episodes
Time Frame
2 YEARS
Title
Number of Hospitalizations
Time Frame
2 years
Title
Hypoglycemia rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pediatric Endocrinology Unit, Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Home and School Visits Intervention for Children With DM TYPE 1
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