| Trial ID: | L5506 |
| Source ID: | NCT03800875
|
| Associated Drug: |
27-Hour Inpatient Intervention
|
| Title: |
Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
|
| Acronym: |
Dual
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: 27-hour inpatient intervention
|
| Outcome Measures: |
Primary: Total percentage of time (22:00-22:00) that the glucose concentration remained within 3.9 and 10.0 mmol/L, 24 hours | Secondary: Total percentage of time (22:00-22:00) that the glucose concentration remained within specified ranges., a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. between 3.9 and 10 mmol/L d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L., 24 hours|Percentage of overnight time (24:00-8:00) that the glucose concentration remained within specified ranges., a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L., 8 hours|Total amount of insulin delivered to the participant, 24 hours|Mean sensor glucose concentration during the overnight stay, 8 hours|Number of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day, 27 hours|The number and severity of gastrointestinal sysmptoms experienced by a participant, GI symptoms include: nausea, vomiting, bloating and heartburn, 27 hours|Mean daytime insulin concentration, 14 hours|Mean daytime concentration of amylin, 14 hours|Total amount of pramlintide delivered to the participant, 24 hours|Mean glucose level, 24-hour period
|
| Sponsor/Collaborators: |
Sponsor: McGill University | Collaborators: Diabetes Canada
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-02-08
|
| Completion Date: |
2020-09-19
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-08
|
| Locations: |
McGill University Health Centre, Montréal, Quebec, H4A 3J1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03800875
|
