gestational diabetes
Conditions
Interventions
Experimental group:adhesive insulin pump treatment
control group:multip insulin injection daily
Sponsors
Shengjing Hospital affiliated to China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand the purpose of the clinical trial, voluntarily participate and have signed an informed consent form; 2. Aged 18 to 45 years old; 3. Body mass index (BMI) at 18.0-38.0 kg/m2; 4. Pre-pregnancy type 2 diabetes with pregnancy: Type 2 diabetes pregnancies that are clearly diagnosed according to WHO diagnostic criteria; 5. Gestational Diabetes: According to the 2017 Chinese Diabetes Care Guidelines: It refers to mild abnormal glucose metabolism during pregnancy, but blood glucose does not reach the level of dominant diabetes, excluding diabetes present before pregnancy. 75gOGTT: FPG=5.1~<7.0mmol/L, blood glucose =10.0mmol/L 1 hour after OGTT, 8.5~<11.1mmol/L 2 hours after OGTT, an abnormality is diagnosed as gestational diabetes; 6. Dominant Diabetes in Pregnancy: According to the 2017 Chinese Diabetes Mellitus Guidelines for Diagnosing Type 2 [6]: Diagnostic criteria for pregnancy found in non-pregnant populations: FPG = 7.0 mmol/L or 2 hours after OGTT = 11.1 mmol/L, or random blood glucose = 11.1 mmol/L. There are no more than three symptoms and repeated measurements on different days, there is still a blood glucose standard; 7. Willing and able to use the meter to monitor fingertip blood glucose and fill out the patient diary card as required; 8. Ability to follow the insulin treatment plan and dietary guidance determined by the investigator.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to insulin, insulin analogues or ingredients in their preparations; 2. Transaminase (ALT/AST) is greater than 2.5 times the upper limit of normal values during screening; 3. Serum creatinine (Cr) at screening is greater than 1.5 times the upper limit of normal; urine protein in urine routine examination = +2; 4. Hypertension: Severe hypertension that cannot be controlled or treated without treatment, defined as systolic blood pressure =150 mmHg and/or diastolic blood pressure =100 mmHg at screening; 5. Except for diseases affecting glucose metabolism; 6. The research doctor judges that poor patient compliance does not complete the study as required, or that other reasons are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting glucose;2h Post-breakfast glucose;HbA1C;pregnancy outcomes; | — |
Countries
China
Contacts
Public ContactLing Li
Shengjing Hospital affiliated to China Medical University
Outcome results
None listed