Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice
NCT ID: NCT03793283
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2019-01-01
2019-12-31
Brief Summary
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Detailed Description
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All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Continous Subcutaneous Insulin Infusion
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.
Forty-five patients are actually treated with CSII in our hospital.
CSII
Currently receiving CSII therapy during 6 or more months.
Multiple dose insulin injections (MDI):
Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI.
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
Multiple dose insulin injections
Currently receiving MDI therapy during 6 or more months.
Interventions
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CSII
Currently receiving CSII therapy during 6 or more months.
Multiple dose insulin injections
Currently receiving MDI therapy during 6 or more months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed of Type 1 Diabetes Mellitus.
* Be attended in Ciudad Real General University Hospital.
* Current treated with CSII (CSII cohort) or MDI (MDI cohort) during ≥6 months.
Exclusion Criteria
* Other types of diabetes mellitus.
18 Years
ALL
No
Sponsors
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University of Castilla-La Mancha
OTHER
Universidad de Córdoba
OTHER
Castilla-La Mancha Health Service
OTHER
Responsible Party
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Jesús Moreno Fernández
Principal investigator
Principal Investigators
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Jesus Moreno-Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
Castilla-La Mancha Public Health Service.
Locations
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Obispo Rafael Torija, St.
Ciudad Real, , Spain
Countries
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Other Identifiers
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C-225
Identifier Type: -
Identifier Source: org_study_id
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