| Trial ID: | L6495 |
| Source ID: | NCT05508061
|
| Associated Drug: |
Insulin Lispro Cartridge [Lyumjev]
|
| Title: |
Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
|
| Acronym: |
FAST 1
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Insulin Lispro Cartridge [Lyumjev]|DRUG: Insulin Lispro Cartridge
|
| Outcome Measures: |
Primary: Percentage of time the glucose level is above 10 mmol/l for the study participants, Time the glucose level is above range (\>10 mmol/l) expressed as a percentage (%), 68 days | Secondary: Safety parameters, Side effects of Lyumjev, 30 days|Pharmacodynamic parameters: euglycemia, Percentage of time the glucose level is between 3.9 and 10 mmol/l (%), 68 days|Pharmacodynamic parameters: hypoglycemia, Percentage of time the glucose level is below 3.9 mmol/l (%), 68 days|Pharmacodynamic parameters: median glucose value, Median of the glucose values (mmol/l), 68 days|Pharmacodynamic parameters: standard deviation of glucose value, Standard deviation of the glucose values (parameter required to determine the coefficient of variation), 68 days|Pharmacodynamic parameters: mean glucose value, Mean of the glucose values (parameter required to determine the coefficient of variation), 68 days|Pharmacodynamic parameters: glycemic variability (CoV), Glycemic variability expressed as the coefficient of variation (CoV): standard deviation divided by the mean of the glucose values (%), 68 days|Pharmacodynamic parameters: glycemic variability (IQR), Glycemic variability expressed as the interquartile range (IQR) (mmol/l), 68 days|AP-related parameters: insulin usage, Daily usage of insulin (units), 68 days|AP-related parameters: glucagon usage, Daily usage of glucagon (units), 68 days|AP-related parameters: algorithm activity, Percentage of time the algorithm is active (%), 68 days
|
| Sponsor/Collaborators: |
Sponsor: Inreda Diabetic B.V.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-19
|
| Completion Date: |
2023-03-16
|
| Results First Posted: |
|
| Last Update Posted: |
2023-04-18
|
| Locations: |
Rijnstate Hospital, Arnhem, Gelderland, 6815 AD, Netherlands|Slingeland Hospital, Doetinchem, Gelderland, 7009 BL, Netherlands|Hospital Gelderse Vallei, Ede, Gelderland, 6716 RP, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT05508061
|
