| Trial ID: | L2405 |
| Source ID: | NCT04163874
|
| Associated Drug: |
Fiasp
|
| Title: |
Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Type 1 Diabetes Mellitus|Hyperglycemia, Postprandial
|
| Interventions: |
DRUG: Fiasp|DRUG: Pramlintide Acetate|DRUG: Placebo|DEVICE: Artificial Pancreas
|
| Outcome Measures: |
Primary: Each participant's time in target range, Time in target range (3.9-10mmol/L), 12 days|Mean score of the Emotional Burden section of the Diabetes Distress Scale, Average of all question's scores (from 1-6). Higher score means more emotional burden., 12 days | Secondary: Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L, 12 days|Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L, 12 days|Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L, 12 days|Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L, 12 days|Each participant's mean glucose level, 12 days|Each participant's standard deviation of glucose levels as a measure of glucose variability, 12 days|Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L, 12 days|Each participant's number of Gastrointestinal symptoms, 12 days|Each participant's total insulin delivery, 12 days
|
| Sponsor/Collaborators: |
Sponsor: McGill University | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-02-14
|
| Completion Date: |
2022-01-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-10-10
|
| Locations: |
3555 University Street, Montreal, Quebec, H3A 2B1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT04163874
|
