Clinical trial NCT04233203: Faster Aspart on Insulin-pump Treated T1DM Patients
Official title: Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: insulin pump
Faster aspart
insulin
glycemic variability
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2020-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.

Brief summary: Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

Detailed description: Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).

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) during ≥6 months.
* Current treated with insulin Faster Aspart during ≥3 months.

Exclusion Criteria:

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

Primary outcomes:
measure: MAGE
timeFrame: 3 months
Secondary outcomes:
measure: VCo
timeFrame: 3 months
measure: M100
timeFrame: 3 months
measure: GRADE
timeFrame: 3 months
measure: J-index
timeFrame: 3 months
measure: MODD
timeFrame: 3 months
measure: CONGA
timeFrame: 3 months
measure: HbA1c
timeFrame: 3 months
measure: Hypoglycemic frequency
timeFrame: 3 months
measure: TIR-TAR-TUR
timeFrame: 3 months
Other outcomes:
measure: Other glycemic outcomes
timeFrame: 3 months
measure: Weigh
timeFrame: 3 months
measure: Insulin dose
timeFrame: 3 months
measure: Local adverse effects
timeFrame: 3 months
measure: Catheters problems
timeFrame: 3 months
measure: Catheter change frequency
timeFrame: 3 months
measure: Severe adverse effects
timeFrame: 3 months
Locations:
city: Ciudad Real
country: Spain
facility: Obispo Rafael Torija, St.
Study officials:
affiliation: Ciudad Real General University Hospital
name: Jose Alberto Garcia Seco, RN
role: STUDY_CHAIR
References: