Faster Aspart on Insulin-pump Treated T1DM Patients

Type 1 Diabetes Clinical Trial

— realFACI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233203
• Other study ID #: C-302
• Status: Completed
• Start date: January 31, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Faster Aspart
Currently receiving Faster Aspart during 3 or more months.

Device:
• Insulin pump
Currently receiving CSII therapy during 6 or more months.

Locations

Country	Name	City	State
Spain	Obispo Rafael Torija, St.	Ciudad Real

Sponsors (2)

Lead Sponsor	Collaborator
Jesús Moreno Fernández	University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Weigh	Differences from basal to 3 months after Faster Aspart initiation on weight	3 months
Other	Insulin dose	Daily insulin doses (basal and bolus) and bolus insulin daily frequency.	3 months
Other	Local adverse effects	Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal.	3 months
Other	Catheters problems	Incidences on insulin-pump catheters: obstructions, deformations.	3 months
Other	Catheter change frequency	Insulin-pump catheter change frequency	3 months
Other	Severe adverse effects	Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death.	3 months
Primary	MAGE	Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).	3 months
Secondary	VCo	Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo).	3 months
Secondary	M100	Differences from basal to 3 months after Faster Aspart initiation on M100.	3 months
Secondary	GRADE	Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE).	3 months
Secondary	J-index	Differences from basal to 3 months after Faster Aspart initiation on J-index.	3 months
Secondary	MODD	Differences from basal to 3 months after Faster Aspart initiation on MODD.	3 months
Secondary	CONGA	Differences from basal to 3 months after Faster Aspart initiation on CONGA.	3 months
Secondary	HbA1c	Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C).	3 months
Secondary	Hypoglycemic frequency	Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency.	3 months
Secondary	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