| Trial ID: | L6118 |
| Source ID: | NCT04053959
|
| Associated Drug: |
Ai Assisted Insulin System
|
| Title: |
Artificial Intelligence Assisted Insulin Titration System
|
| Acronym: |
iNCDSS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: AI assisted insulin system|DRUG: Physician based insulin regime
|
| Outcome Measures: |
Primary: Proportion of time in target range, The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L), During 7-day intervention | Secondary: Proportion of time in which the blood glucose level is over 10 mmol/L, The poor control of blood glucose level is defined as greater than 10 mmol/L, During 7-day intervention|Proportion of time in which the blood glucose level is below 3.9 mmol/L, The hypoglycemia is defined as blood glucose level less than 3.9mmol/L, During 7-day intervention|Total insulin dose, The total insulin dose is defined as daily insulin dose, Each day during 7-day intervention
|
| Sponsor/Collaborators: |
Sponsor: Shanghai Zhongshan Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
46
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-27
|
| Completion Date: |
2020-04-15
|
| Results First Posted: |
|
| Last Update Posted: |
2020-07-27
|
| Locations: |
180 Fenglin Road, Shanghai, 200032, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04053959
|
