Clinical trial NCT03793283: Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice
Official title: Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
name: Universidad de Córdoba
First posted: 2019-01-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.

MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Hemoglobin A1C (HbA1C).
timeFrame: 1 year
Secondary outcomes:
measure: Hypoglycemia frequency.
timeFrame: 1 year
measure: Concentration of Capillary blood glucose.
timeFrame: 1 year
measure: Concentration of Interstitial blood glucose.
timeFrame: 1 year
measure: Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.
timeFrame: 1 year
measure: Glycemic variability: standar deviation of capilary/interstitial blood glucose.
timeFrame: 1 year
measure: Self-monitoring of blood glucose (SMBG) daily frequency
timeFrame: 1 year
measure: Severe hypoglycemia frequency.
timeFrame: 1 year
measure: Weight.
timeFrame: 1 year
measure: Insuline dose.
timeFrame: 1 year
measure: Diabetes quality of life (DQOL).
timeFrame: 1 year.
measure: Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable
timeFrame: 1 year
measure: Unawareness hypoglycemia.
timeFrame: 1 year.
measure: Safety related adverse events.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ciudad Real
country: Spain
facility: Obispo Rafael Torija, St.
Study officials:
affiliation: Castilla-La Mancha Public Health Service.
name: Jesus Moreno-Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: