Faster Aspart on Insulin-pump Treated T1DM Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin Faster Aspart
* Device: Insulin pump


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Faster Aspart<br>All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart. | Drug: Insulin Faster Aspart<br>* Currently receiving Faster Aspart during 3 or more months.<br>* Other names: Fiasp;Device: Insulin pump<br>* Currently receiving CSII therapy during 6 or more months.<br>* Other names: Accucheck Insight;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAGE | Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VCo | Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo). | 3 months | 
| M100 | Differences from basal to 3 months after Faster Aspart initiation on M100. | 3 months | 
| GRADE | Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE). | 3 months | 
| J-index | Differences from basal to 3 months after Faster Aspart initiation on J-index. | 3 months | 
| MODD | Differences from basal to 3 months after Faster Aspart initiation on MODD. | 3 months | 
| CONGA | Differences from basal to 3 months after Faster Aspart initiation on CONGA. | 3 months | 
| HbA1c | Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C). | 3 months | 
| Hypoglycemic frequency | Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency. | 3 months | 
| TIR-TAR-TUR | 9. Differences from basal to 3 months after Faster Aspart initiation on time in range, time above range and time under range. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin pump, Faster aspart, insulin, glycemic variability