| Trial ID: | L5114 |
| Source ID: | NCT05084079
|
| Associated Drug: |
Csii With Formula-Based Initial Insulin Regimen
|
| Title: |
Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Diabetes Mellitus, Type 2|Glucose Metabolism Disorders|Metabolic Disease|Endocrine System Diseases
|
| Interventions: |
DRUG: CSII with formula-based initial insulin regimen|DRUG: CSII with weight-based initial insulin regimen
|
| Outcome Measures: |
Primary: The time to glycemic goal, After CSII begin, the time(days) to reach glycemic goal of each patients. The glycemic goal defined as at least six out of eight-point fingertip blood glucose meet the standard that fasting blood glucose(FBG) or non-postprandial blood glucose is between 4.4-6.0 mmol/L and 2h postprandial blood glucose(PBG) is between 4.4-8.0 mmol/L., 1 year | Secondary: Incidence of hypoglycemia, Differences in incidence of hypoglycemia among treatment arms at the end of study., 1 year|Change of blood glucose fluctuations, Differences in blood glucose fluctuations among treatment arms at the end of study., 1 year|Change of β cell function, Differences in β-cell indicators among treatment arms at the end of study., 1 year|Change of insulin sensitivity, Differences in insulin sensitivity indicators among treatment arms at the end of study., 1 year|Change of insulin dosage, Differences in insulin dosage among treatment arms at the end of study., 1 year
|
| Sponsor/Collaborators: |
Sponsor: Sun Yat-sen University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-11
|
| Completion Date: |
2022-10
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-19
|
| Locations: |
endocrinology department of the first affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05084079
|
