NCT04233203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 15, 2020

Last Update Submit

January 29, 2021

Conditions

Type 1 Diabetes

Keywords

insulin pumpFaster aspartinsulinglycemic variability

Outcome Measures

Primary Outcomes (1)

  • MAGE

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

    3 months

Secondary Outcomes (9)

  • VCo

    3 months

  • M100

    3 months

  • GRADE

    3 months

  • J-index

    3 months

  • MODD

    3 months

  • +4 more secondary outcomes

Other Outcomes (7)

  • Other glycemic outcomes

    3 months

  • Weigh

    3 months

  • Insulin dose

    3 months

  • +4 more other outcomes

Study Arms (1)

Faster Aspart

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

Drug: Insulin Faster AspartDevice: Insulin pump

Interventions

Insulin Faster AspartDRUG

Currently receiving Faster Aspart during 3 or more months.

Also known as: Fiasp
Faster Aspart
Insulin pumpDEVICE

Currently receiving CSII therapy during 6 or more months.

Also known as: Medtronic 640G, Medtronic 670G, T Slim X2, Accucheck Insight
Faster Aspart

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.

You may qualify if:

  • ≥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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37356876DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Interventions

Insulin AspartInsulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDrug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Jose Alberto Garcia Seco, RN

    Ciudad Real General University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Endocrinology and Nutrition Service, MD, PhD Affiliation: Castilla-La Mancha Health Service

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

January 31, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

ES(1)