Type 2 Diabetes Mellitus
Conditions
Interventions
Group A:Phase I: MDI regimen
Phase II: CSII regimen.
Group B:Phase I: CSII regimen
Phase II: MDI regimen
Sponsors
Zhujiang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years to 60 years, men or women; 2. 18.5kg/m2=BMI=32 kg/m2; 3. Course of T2DM longer than 6 months; 4. HbA1c above 7% after 2 or more than 2 types oral hypoglycemic therapy with maximum tolerated over 3 months; 5. Willing to accept intensive insulin treatment, and never applied this treatment before; 6. Willing to wear a continuous glucose monitor system; 7. Voluntarily to participate and cooperate.
Exclusion criteria
Exclusion criteria: 1. With acute complication like ketoacidosis / hyperglycemic hyperosmolar status / lactic acidosis; 2. Older, poorer physique, high risk of hypoglycemia, shorter life expectancy, T2DM patients with severe chronic complications or associated disease; 3. Pregnant women or women who are pregnant or planning to be pregnant during the study; 4. Have a disease that affects glucose metabolism or have taken drugs that interfere with glucose metabolism; 5. Allergic reactions or contraindications to drugs or instruments using in the study such as insulin, insulin pump, dynamic glucose monitor, etc. 6. Use drugs influencing the veracity of continuous glucose monitor system such as salicylic acid, ascorbic acid and so on; 7. Patients with clinically significant hepatobiliary disorders, including but not limited to chronic active hepatitis and / or severe liver dysfunction. ALT or AST> 3 times the normal upper limit (ULN) or serum total bilirubin (TB)> 34.2 µmol/L (> 2 mg / dL); 8. Patients with clinically significant nephrotic disorders; 9. Poor control of Severe hypertension, SBP = 160 mmHg and / or DBP = 100 mmHg; SBP <96 mmHg; 10. Patients with myocardial infarction / unstable angina / severe arrhythmia / heart failure in the past 3 months; 11. Patients that might not follow this program, or with severe physical/mental illness that may affect effectiveness or safety, based on the judgement of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Amplitude of Glycemic Excursions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coefficient of Variation;Maximum Amplitude of Glycemic Excursions;Absolute Means of Daily Differences;Total daily dose of insulin;time of reaching target of glucose;Glycosylated Serum Protein;plasma glucose of fasting and 2 hours after breakfast;peptide C of fasting and 2 hours after breakfast;The rate of hypoglycemia; | — |
Countries
China
Contacts
Public ContactJia Sun
Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University
Outcome results
None listed