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Assessment of the Impact of CSII versus MDI on Glycemic Variability in Type 2 Diabetes Using Continuous Glucose Monitoring

Assessment of the Impact of CSII versus MDI on Glycemic Variability in Type 2 Diabetes Using Continuous Glucose Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128079
Enrollment
Unknown
Registered
2026-07-14
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

Insulin pump continuous subcutaneous insulin infusion group:None
The group with multiple daily insulin injections:None

Sponsors

The 958th Hospital of the Chinese People's Liberation Army Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-70 years old; 2. Meet the diagnostic criteria for type 2 diabetes set by the World Health Organization (WHO) in 2011; 3. After lifestyle intervention and standardized treatment with two or more oral hypoglycemic drugs for at least 3 months, blood glucose remains poorly controlled, HbA1c is between 7.5% and 14.0%, or for newly diagnosed patients, HbA1c is >=9.0% or fasting blood glucose is >=11.1 mmol/L, or accompanied by obvious hyperglycemic symptoms; 4. Possess good cognitive and communication skills, and be able to understand and cooperate with the research process; 5. Fasting C-peptide level > 0.2 ng/mL; 6. Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes, gestational diabetes or other special types of diabetes; 2. Within 3 months, there were diabetic ketoacidosis, hyperglycemic hyperosmolar states, and severe hypoglycemic events; 3. There is severe heart, liver or kidney insufficiency (meeting any of the following conditions) : AST or ALT>3 times the upper limit of normal, or TBIL>1.5 times the upper limit of normal; eGFR<30ml/min/1.73m^2 or dialysis has been completed; Cardiac color Doppler ultrasound indicates LVEF<=30% or NYHA grade III or above; 4. Suffering from other serious endocrine diseases that affect blood sugar or insulin metabolism; 5. There is an active malignant tumor; 6. There are severe skin infections, allergies or conditions where wearing is not suitable at the location of the CGM sensor or insulin pump infusion pipeline. 7. Having a history of mental illness or drug or alcohol abuse, etc., and being unable to cooperate with the researcher; 8. Women who plan to become pregnant, are currently pregnant or breastfeeding during the study period.

Design outcomes

Primary

MeasureTime frame
The time required for blood sugar to reach the target level;The time to reach the target blood sugar level within the specified range;The time when blood sugar is above the target range;The time when blood sugar is below the target range;Standard Deviation of Glucose;Mean Amplitude of Glycemic Excursions;glycated hemoglobin;Pancreatic islet function-related indicators (fasting C-peptide, fasting insulin levels and HOMA2 model);

Secondary

MeasureTime frame
Hypoglycemia and other adverse events;Patient treatment satisfaction;Quality of life of patients;

Countries

china

Contacts

Public ContactYang Li

The 958th Hospital of the Army

m202218785598976@163.com+86 187 8559 8976

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026