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OpenTrials
Completed

NCT Number: NCT02137174

Home and School Visits Intervention for Children With DM TYPE 1

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

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatric Endocrinology Unit, Soroka Medical Center

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home and school visits

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.

Primary outcomes

  1. HBA1C

    Time frame: 2 YEARS

Secondary outcomes

  1. Number of DKA episodes

    Time frame: 2 YEARS

  2. Number of Hospitalizations

    Time frame: 2 years

  3. Hypoglycemia rate

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ben-Gurion University of the Negev

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 13, 2014
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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