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Effects of Continuous Glucose Monitoring on Patients With Type 2 Diabetes Treated With Insulin During Post-Discharge Transition: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The transition from inpatient care to the home setting is a critical phase for glycemic management, often associated with decreased adherence and deterioration of glycemic control. This multicenter, randomized, open-label, controlled trial aims to evaluate the efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) versus Self-Monitoring of Blood Glucose (SMBG) in patients with Type 2 Diabetes Mellitus (T2DM) treated with insulin during the post-discharge transitional period. A total of 160 eligible participants will be randomized in a 1:1 ratio to either the RT-CGM group or the SMBG group. Participants will wear RT-CGM intermittently (every 4 weeks) or perform SMBG for the 12-week intervention period. They will also visit the clinic at Week 12 and Week 24 for follow-up assessments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18 to 80 years (inclusive).

• Confirmed diagnosis of type 2 diabetes mellitus (T2DM).

• HbA1c between 8.0% and 13.0% (inclusive) within the last 1 month prior to screening/enrollment.

• Planned to receive insulin therapy for at least 6 months after hospital discharge, as assessed/confirmed by the treating physician (principal physician).

Locations
Other Locations
China
Shanghai 6th People's Hospital
RECRUITING
Shanghai
Shanghai 7th People's Hospital
RECRUITING
Shanghai
Shanghai Fengxian District Central Hospital
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jian Zhou
zhoujian@sjtu.edu.cn
86-21-64369181
Time Frame
Start Date: 2026-05-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Intervention group (RT-CGM Group)
Participants in this group will use a Real-Time Continuous Glucose Monitoring (RT-CGM) system intermittently during the 12-week intervention period, followed by a 14-week follow-up period.
Active_comparator: Control Group (SMBG Group)
Participants in this group will perform standard Self-Monitoring of Blood Glucose (SMBG) using a blood glucose meter throughout the 12-week intervention period, followed by a 14-week follow-up period.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai 7th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Fengxian District Central Hospital
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov

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