Glycemic Remission, Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy
Conditions
Brief summary
Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.
Interventions
DRUGSimplified intensive insulin therapy regimen
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.
DRUGTraditional Short-term Intensive insulin therapy
Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| remission rate | 24 weeks after withdrawal of the medical intervention | Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents |
Countries
China
Outcome results
None listed