Type 1 Diabetes
Conditions
Keywords
insulin pump, Faster aspart, insulin, glycemic variability
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.
Detailed 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.
Interventions
DRUGInsulin Faster Aspart
Currently receiving Faster Aspart during 3 or more months.
DEVICEInsulin pump
Currently receiving CSII therapy during 6 or more months.
Sponsors
University of Castilla-La Mancha
Jesús Moreno Fernández
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAGE | 3 months | Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| M100 | 3 months | Differences from basal to 3 months after Faster Aspart initiation on M100. |
| GRADE | 3 months | Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE). |
| J-index | 3 months | Differences from basal to 3 months after Faster Aspart initiation on J-index. |
| MODD | 3 months | Differences from basal to 3 months after Faster Aspart initiation on MODD. |
| CONGA | 3 months | Differences from basal to 3 months after Faster Aspart initiation on CONGA. |
| HbA1c | 3 months | Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C). |
| Hypoglycemic frequency | 3 months | Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency. |
| TIR-TAR-TUR | 3 months | 9\. Differences from basal to 3 months after Faster Aspart initiation on time in range, time above range and time under range. |
| VCo | 3 months | Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insulin dose | 3 months | Daily insulin doses (basal and bolus) and bolus insulin daily frequency. |
| Local adverse effects | 3 months | Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal. |
| Catheters problems | 3 months | Incidences on insulin-pump catheters: obstructions, deformations. |
| Catheter change frequency | 3 months | Insulin-pump catheter change frequency |
| Severe adverse effects | 3 months | Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death. |
| Weigh | 3 months | Differences from basal to 3 months after Faster Aspart initiation on weight |
| Other glycemic outcomes | 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. |
Countries
Spain
Outcome results
None listed