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Completed

NCT Number: NCT04233203

Faster Aspart on Insulin-pump Treated T1DM Patients

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Faster Aspart

Drug

Currently receiving Faster Aspart during 3 or more months.

Other names: Fiasp

Insulin pump

Device

Currently receiving CSII therapy during 6 or more months.

Other names: Medtronic 640G, Medtronic 670G, T Slim X2, Accucheck Insight

Primary outcomes

  1. MAGE

    Time frame: 3 months

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

Secondary outcomes

  1. VCo

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo).

  2. M100

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on M100.

  3. GRADE

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE).

  4. J-index

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on J-index.

  5. MODD

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on MODD.

  6. CONGA

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on CONGA.

  7. HbA1c

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C).

  8. Hypoglycemic frequency

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency.

  9. TIR-TAR-TUR

    Time frame: 3 months

    • Differences from basal to 3 months after Faster Aspart initiation on time in range, time above range and time under range.

Other outcomes

  1. Other glycemic outcomes

    Time frame: 3 months

    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.

  2. Weigh

    Time frame: 3 months

    Differences from basal to 3 months after Faster Aspart initiation on weight

  3. Insulin dose

    Time frame: 3 months

    Daily insulin doses (basal and bolus) and bolus insulin daily frequency.

  4. Local adverse effects

    Time frame: 3 months

    Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal.

  5. Catheters problems

    Time frame: 3 months

    Incidences on insulin-pump catheters: obstructions, deformations.

  6. Catheter change frequency

    Time frame: 3 months

    Insulin-pump catheter change frequency

  7. Severe adverse effects

    Time frame: 3 months

    Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death.

Sponsors and collaborators

Lead sponsor

Jesús Moreno Fernández

Other

Collaborators

  • University of Castilla-La Mancha

Registry information

Official study title

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

Acronym: realFACI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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