RT-CGM: This group of patients will wear RT-CGM for blood glucose monitoring for three months.
SMBG: This group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week.
Study summary
Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. 18 years old ≤ age ≤ 80 years old.
2. Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
3. 8% ≤ HbA1c ≤ 12% in the last 1 month.
4. Insulin therapy within 1 month of planned discharge from hospital.
5. 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.
6. Willing and able to provide written informed consent and comply with the requirements of this study.
Exclusion Criteria:
1. Oral steroid hormone therapy.
2. Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
3. Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
4. Patients with severe kidney injury or end-stage renal disease (eGFR \< 30 mL/min/1.73 m2).
5. 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.
6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
7. Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.
Primary outcome measure(s)
Time in range (3.9~10.0mmol/L, %) — 12 weeks Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
Trial sites (1)
Facility
City
Region
Status
Shanghai 6th People's Hospital
Shanghai
Shanghai Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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