Faster Aspart on Insulin-pump Treated T1DM Patients

NCT ID: NCT04233203

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-12-31

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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Faster Aspart

All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.

Insulin Faster Aspart

Intervention Type DRUG

Currently receiving Faster Aspart during 3 or more months.

Insulin pump

Intervention Type DEVICE

Currently receiving CSII therapy during 6 or more months.

Interventions

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Insulin Faster Aspart

Currently receiving Faster Aspart during 3 or more months.

Intervention Type DRUG

Insulin pump

Currently receiving CSII therapy during 6 or more months.

Intervention Type DEVICE

Other Intervention Names

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Fiasp Medtronic 640G Medtronic 670G T Slim X2 Accucheck Insight

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role collaborator

Jesús Moreno Fernández

OTHER

Sponsor Role lead

Responsible Party

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Jesús Moreno Fernández

Endocrinology and Nutrition Service, MD, PhD Affiliation: Castilla-La Mancha Health Service

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose Alberto Garcia Seco, RN

Role: STUDY_CHAIR

Ciudad Real General University Hospital

Locations

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Obispo Rafael Torija, St.

Ciudad Real, , Spain

Site Status

Countries

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Spain

References

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Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Munoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. Endocrinol Diabetes Nutr (Engl Ed). 2023 Jun-Jul;70(6):389-395. doi: 10.1016/j.endien.2021.12.012.

Reference Type DERIVED
PMID: 37356876 (View on PubMed)

Other Identifiers

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C-302

Identifier Type: -

Identifier Source: org_study_id

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