| Trial ID: | L1834 |
| Source ID: | NCT04853030
|
| Associated Drug: |
Fiasp
|
| Title: |
Fast Advanced Closed-Loop Therapy
|
| Acronym: |
FACT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Fiasp|DRUG: Novorapid
|
| Outcome Measures: |
Primary: 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 | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: University of Ljubljana, Faculty of Medicine | Collaborators: Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria|UMC Ljubljana University Children's Hospital Ljubljana
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-06
|
| Completion Date: |
2021-09-20
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-01
|
| Locations: |
Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria|UMC Ljubljana University Children's Hospital Ljubljana, Ljubljana, 1000, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT04853030
|
