Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission

Study Overview
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Brief Summary
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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.

Official Title
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Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial.

Conditions
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Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy, Glycemic Remission

Intervention / Treatment
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* Drug: Simplified intensive insulin therapy regimen
* Drug: Traditional Short-term Intensive insulin therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simplified regimen group<br>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<br>* 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.<br>|
| Active Comparator: Routine group<br>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<br>* Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |