| Trial ID: | L6686 |
| Source ID: | NCT04642378
|
| Associated Drug: |
Incdss Based Insulin Regime
|
| Title: |
Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
iNCDSS-3
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: iNCDSS based insulin regime|DRUG: routine insulin treatment regime
|
| Outcome Measures: |
Primary: Time in target glucose 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 5-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 5-day intervention|Proportion of hypoglycemia, The hypoglycemia is defined as blood glucose level less than 3.0mmol/L, During 5-day intervention|Daily insulin dose, The daily insulin dose is defined as daily total insulin dose, During 5-day intervention
|
| Sponsor/Collaborators: |
Sponsor: Shanghai Zhongshan Hospital | Collaborators: Shanghai Fifth People's Hospital,Fudan University|XuHui Central Hospital of Shanghai, Shanghai, China
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
149
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2021-10-01
|
| Completion Date: |
2022-09-08
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-16
|
| Locations: |
180 Fenglin Road, Shanghai, 200032, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04642378
|
