Faster Aspart on Insulin-pump Treated T1DM Patients

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin Faster Aspart; Device: Insulin pump

• Registration Number: NCT04233203
• Lead Sponsor: Jesús Moreno Fernández

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-01-31
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Faster Aspart	Insulin Faster Aspart	All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.
Faster Aspart	Insulin pump	All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.

Primary Outcome Measures

Name	Time	Method
MAGE	3 months	Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Obispo Rafael Torija, St.; 🇪🇸 Ciudad Real, Spain