An observational study in Type 1 Diabetes, sponsored by Jesús Moreno Fernández. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Jesús Moreno Fernández · Observational
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.
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 48 is below the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Jesús Moreno Fernández is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.
Drug: Insulin Faster Aspart · Device: Insulin pump
Currently receiving Faster Aspart during 3 or more months.
Also known as: Fiasp
Currently receiving CSII therapy during 6 or more months.
Also known as: Medtronic 640G, Medtronic 670G, T Slim X2, Accucheck Insight
MAGE
Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).
Time frame: 3 months
VCo
Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo).
Time frame: 3 months
M100
Differences from basal to 3 months after Faster Aspart initiation on M100.
Time frame: 3 months
GRADE
Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE).
Time frame: 3 months
J-index
Differences from basal to 3 months after Faster Aspart initiation on J-index.
Time frame: 3 months
MODD
Differences from basal to 3 months after Faster Aspart initiation on MODD.
Time frame: 3 months
CONGA
Differences from basal to 3 months after Faster Aspart initiation on CONGA.
Time frame: 3 months
HbA1c
Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C).
Time frame: 3 months
Hypoglycemic frequency
Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Weigh
Differences from basal to 3 months after Faster Aspart initiation on weight
Time frame: 3 months
Insulin dose
Daily insulin doses (basal and bolus) and bolus insulin daily frequency.
Time frame: 3 months
Local adverse effects
Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal.
Time frame: 3 months
Catheters problems
Incidences on insulin-pump catheters: obstructions, deformations.
Time frame: 3 months
Catheter change frequency
Insulin-pump catheter change frequency
Time frame: 3 months
Severe adverse effects
Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death.
Time frame: 3 months
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Jesús Moreno Fernández