Faster Aspart on Insulin-pump Treated T1DM Patients (realFACI)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin Faster Aspart; Device: Insulin pump

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real, Spain, 13005
    • Obispo Rafael Torija, St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Faster Aspart; All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.	Drug: Insulin Faster Aspart; Currently receiving Faster Aspart during 3 or more months.; Other Names: Fiasp; Device: Insulin pump; Currently receiving CSII therapy during 6 or more months.; Other Names: Medtronic 640G; Medtronic 670G; T Slim X2; Accucheck Insight

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other glycemic outcomes	Other glycemic control differences from basal to 3 months after Faster Aspart initiation: capillary blood glucose, interstitial blood glucose, self-monitoring of blood glucose (SMBG) daily frequency, severe hypoglycemia frequency.	3 months
Weigh	Differences from basal to 3 months after Faster Aspart initiation on weight	3 months
Insulin dose	Daily insulin doses (basal and bolus) and bolus insulin daily frequency.	3 months
Local adverse effects	Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal.	3 months
Catheters problems	Incidences on insulin-pump catheters: obstructions, deformations.	3 months
Catheter change frequency	Insulin-pump catheter change frequency	3 months
Severe adverse effects	Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death.	3 months

Collaborators and Investigators

• Sponsor: Jesús Moreno Fernández
• Collaborators: University of Castilla-La Mancha
• Investigators: Study Chair: Jose Alberto Garcia Seco, RN, Ciudad Real General University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: insulin pump; insulin; glycemic variability; Faster aspart
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: C-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No