Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice (real-ECIMI)

Castilla-La Mancha Health Service

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Multiple dose insulin injections; Device: CSII

Study type: Observational

Funder types: Other

Identifiers

NCT03793283

C-225

Details and patient eligibility

About

Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.

Full description

Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age.
• 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

• Less than 18 years old.
• Other types of diabetes mellitus.

Trial design

90 participants in 2 patient groups

Continous Subcutaneous Insulin Infusion

Description:

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.

Treatment:

Device: CSII

Multiple dose insulin injections (MDI):

Description:

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.

Treatment:

Drug: Multiple dose insulin injections