Status:
RECRUITING
Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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,...
Detailed Description
Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CG...
Eligibility Criteria
Inclusion
- 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
- Oral steroid hormone therapy.
- 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.
Key Trial Info
Start Date :
October 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06591286
Start Date
October 25 2024
End Date
September 30 2027
Last Update
November 29 2024
Active Locations (1)
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1
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China, 200233