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Effects of real-time continuous glucose monitoring system on hospital-to-home transitional blood glucose control and self-efficacy among patients with type 2 diabetes treated with insulin

Effects of real-time continuous glucose monitoring system on hospital-to-home transitional blood glucose control and self-efficacy among patients with type 2 diabetes treated with insulin

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089151
Enrollment
Unknown
Registered
2024-09-03
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Type 2 diabetes

Interventions

rtCGM group:Experimental: Real-time Continues Glucose Monitoring system
SMBG group:Control: Self-monitoring of blood glucose

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? 18 years old = age = 80 years old; ? Type 2 diabetes admitted to Department of Endocrinology and Metabolism; ? 8% = HbA1c = 12% in the last 1 month; ? Insulin therapy within 1 month of planned discharge from hospital; ? Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation; ? Willing and able to provide written informed consent and comply with the requirements of this study;

Exclusion criteria

Exclusion criteria: ? Oral steroid hormone therapy. ? Any of the following cardiovascular diseases within the last 6 months. a. Myocardial infarction. b. Cardiac surgery or haemodialysis (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty). ? Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis) ? Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal). ? Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2). ? Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area. ? Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. ? Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.

Design outcomes

Secondary

MeasureTime frame
Diabetes Self-Efficacy Scale;HbA1c;Time above range (>10 mmol/L, %);Time below range (<3.9 mmol/L, %);Mean glucose;Coefficient of variation of sensor glucose;Standard deviation of sensor glucose;Mean amplitude of glycemic excursions;

Primary

MeasureTime frame
Time in range (3.9-10 mmol/L, %);

Countries

China

Contacts

Public ContactShiyun Wang

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

rhyme2008@alumni.sjtu.edu.cn+86 21 2405 8570

Outcome results

None listed

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