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Efficacy comparison of patch insulin pump with conventional insulin pump in patients with type 2 diabetes mellitus

Efficacy comparison of patch insulin pump with conventional insulin pump in patients with type 2 diabetes mellitus

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043778
Enrollment
Unknown
Registered
2021-02-28
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

type 2 diabetes mellitus

Interventions

A:phase I: patch insulin pump
phase II: conventional insulin pump
B:phase I: conventional insulin pump
phase II: patch insulin pump.

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participate voluntarily and sign subject informed consent before the study. 2) Age 18 years or older and 75 years or less. 3) Patients diagnosed with type 2 diabetes by WHO1999 diagnostic criteria. 4) BMI greater than 18 kg/m2 and less than 35 kg/m2. 5) Fasting blood glucose less than 16.7 mmolL and postprandial blood glucose or random blood glucose less than 22.2 mmol/L;HbA1c greater than 8% in patients newly diagnosed and 7% in patients already receiving hypoglycemic therapy. 6) Patiets without acute complications of diabetes include diabetic ketoacidosis and diabetic hyperosmolar syndrome 7) Patients are able and willing to perform blood glucose monitoring, insulin pump therapy, diet and exercise regularly.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes, Late onset autoimmune diabetes in adults, secondary diabetes, gestational diabetes and Stress hyperglycemia. 2) Impaired liver or kidney function 3) Patients with severe anemia, Hb less than 60g/L. 4) Patients with drug abuse or alcohol dependence in the past 5 years. 5) Repetitive severe hypoglycemia determined by researcher. 6) Patients with a history of 3 or more consecutive days of hormone therapy and/or current use of systemic hormone therapy within 3 months before enrolment. 7) Decompensated heart failure, unstable angina, or ACS within 12 months. 8) Allergy to experimental drug or related products. 9) Pregnant and lactation patients. 10) Patients with poor compliance, inability to cooperate with intensive treatment, irregular diet and exercise. 11) Any other apparent condition or complicating disease determined by researcher.

Design outcomes

Primary

MeasureTime frame
Dynamic glucose profile;

Secondary

MeasureTime frame
Treatment satisfaction;

Countries

China

Contacts

Public ContactZhu Jian

Nanjing First Hospital

595268917@qq.com+86 18951670936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026