CGM for Insulin-Treated T2DM During Post-Discharge Transition (TRANSIT-CGM)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Device: SMBG; Device: RT-CGM

Study type: Interventional

Funder types: Other

Identifiers

NCT07414277

20260203

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 80 years (inclusive).
2. Confirmed diagnosis of type 2 diabetes mellitus (T2DM).
3. HbA1c between 8.0% and 13.0% (inclusive) within the last 1 month prior to screening/enrollment.
4. Planned to receive insulin therapy for at least 6 months after hospital discharge, as assessed/confirmed by the treating physician (principal physician).

Exclusion criteria

1. Current use of a real-time continuous glucose monitoring (RT-CGM) device, or use within the 3 months prior to enrollment.
2. Severe skin disease at the sensor insertion site, or allergy to adhesive tape/adhesives.
3. Pregnant women; positive pregnancy test at screening; or planning pregnancy during the study period.
4. Currently participating in, or planning to participate in, another clinical trial.
5. Current use of oral corticosteroid therapy, or anticipated use during the trial period.
6. Severe liver disease, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN).
7. Severe renal impairment or end-stage renal disease, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
8. Any condition that, in the investigator's opinion, makes the participant unsuitable for the trial, for example: history of ocular trauma or other diagnosed eye diseases causing visual impairment; unwillingness to participate or inability to adequately understand/comply due to speech/language impairment; or presence of psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention group (RT-CGM Group)

Experimental group

Description:

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.

Treatment:

Device: RT-CGM

Control Group (SMBG Group)

Active Comparator group

Description:

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.

Treatment:

Device: SMBG