Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: RT-CGM; Device: SMBG

Study type: Interventional

Funder types: Other

Identifiers

NCT06591286

RT20240903

Details and patient eligibility

About

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.

Full 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-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.

One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group (75 cases) will wear real-time CGM to monitor blood glucose for 12 weeks, followed by 36 weeks of follow-up.

Treatment:

Device: RT-CGM

Control group

Other group

Description:

The control group (75 cases) is self-monitored by traditional SMBG for 12 weeks at a frequency of no less than 4 times a week, followed by 36 weeks of follow-up.

Treatment:

Device: SMBG