Effects of Structured Simplified Short-term Intensive Ins... | NCT03972982

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simplified regimen group	Experimental	Short-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week，Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management.	Drug: Simplified intensive insulin therapy regimen
Routine group	Active Comparator	Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.	Drug: Traditional Short-term Intensive insulin therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simplified intensive insulin therapy regimen	Drug	Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.

Measure	Description	Time Frame
remission rate	Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents	24 weeks after withdrawal of the medical intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;
GHbA1c ≥ 9%
Body mass index between 20-35kg/m2
Capable to use wearable devices and mobile Apps;
willling to follow the study protocol and data collection.

Exclusion Criteria:

Type 1 diabetes or specific types of diabetes;
Allergic or intolercance to medicine used in the study;
Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;
Glomerular filtration rate less than 50 ml/min
ALT >2.5 times of the upper limit of normal (ULN), or bilirubin > 1.5 times of ULN；
Significant Macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment;
Poor blood pressure control (systolic blood pressure≥180mmHg and/or sitting diastolic blood pressure ≥110mmHg) and unable to control under 160/110mmhg within 1 week;
Hemoglubin level < 100g/L or required regular blood transfusion;
Chronic cardiac dysfunction with NYHA grade III or above;
Use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic replacement of thyroid hormone are allowed;
Serious systemic disease or malignant tumor, chronic diarrhea, etc；
Uncontrolled abnormalty in endocrine glands (Cushing's syndrome, hyperthyroidism, etc.);
Any factors that may affect the participation of the subject in the study or the evaluation of the results；
Pregnancy or planned pregnancy, lactation subjects.