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| Name | Class |
|---|---|
| University of Castilla-La Mancha | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faster Aspart | All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Faster Aspart | Drug | Currently receiving Faster Aspart during 3 or more months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MAGE | Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| VCo | Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo). | 3 months |
| M100 | Differences from basal to 3 months after Faster Aspart initiation on M100. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Weigh |
Inclusion Criteria:
Exclusion Criteria:
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Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Jose Alberto Garcia Seco, RN | Ciudad Real General University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obispo Rafael Torija, St. | Ciudad Real | 13005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37356876 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin pump | Device | Currently receiving CSII therapy during 6 or more months. |
|
|
| 3 months |
| GRADE | Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE). | 3 months |
| J-index | Differences from basal to 3 months after Faster Aspart initiation on J-index. | 3 months |
| MODD | Differences from basal to 3 months after Faster Aspart initiation on MODD. | 3 months |
| CONGA | Differences from basal to 3 months after Faster Aspart initiation on CONGA. | 3 months |
| HbA1c | Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C). | 3 months |
| Hypoglycemic frequency | Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency. | 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. | 3 months |
Differences from basal to 3 months after Faster Aspart initiation on weight |
| 3 months |
| Insulin dose | Daily insulin doses (basal and bolus) and bolus insulin daily frequency. | 3 months |
| Local adverse effects | Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal. | 3 months |
| Catheters problems | Incidences on insulin-pump catheters: obstructions, deformations. | 3 months |
| Catheter change frequency | Insulin-pump catheter change frequency | 3 months |
| Severe adverse effects | Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death. | 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |