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Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

NCT03697369 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-10-05

No results posted yet for this study

Summary

Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.

Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .

Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.

Conditions

  • T1DM

Sponsors & Collaborators

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Maccabi Healthcare Services, Israel

    collaborator OTHER

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-07-31
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697369 on ClinicalTrials.gov