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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
| UMC Ljubljana University Children's Hospital Ljubljana | UNKNOWN |
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A double-blind, multinational, multicenter, randomised, 2-period crossover study to assess the efficacy and safety of advanced closed-loop insulin delivery with Minimed 670G 4.0 system comparing Faster Insulin Aspart to Standard Insulin Aspart therapy over 4 weeks in active children and adolescents with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimed 670G 4.0 closed loop with Faster Insulin aspart | Experimental |
| |
| Minimed 670G 4.0 closed loop with Standard Insulin aspart | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiasp | Drug | Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time above range 180 mg/dl | The primary outcomes is a difference in CGM-measured metrics between periods (Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart) in superiority for proportion of time >180 mg/dL (10.0 mmol/L) | 12 weeks for each arm of the crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range 70-180 mg/dl | CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time in range 70 to 180 mg/dL (3.9 to 10.0 mmol/L | 4 weeks for each arm of the crossover |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz Department of Pediatrics and Adolescent Medicine | Graz | Austria | ||||
| UMC Ljubljana University Children's Hospital Ljubljana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37404205 | Derived | Dovc K, Bergford S, Frohlich-Reiterer E, Zaharieva DP, Potocnik N, Muller A, Lenarcic Z, Calhoun P, Fritsch M, Sourij H, Bratina N, Kollman C, Battelino T. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023 Sep;25(9):612-621. doi: 10.1089/dia.2023.0178. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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 |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Blinded insulin formulation (Faster and Standard Insulin Aspart)
| Novorapid | Drug | Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid |
|
| Time below range <70 mg/dl |
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time below range 70 mg/dl |
| 4 weeks for each arm of the crossover |
| Mean glucose | CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in mean glucose | 4 weeks for each arm of the crossover |
| Ljubljana |
| 1000 |
| Slovenia |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |