CGM for Insulin-Treated T2DM During Post-Discharge Transition

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes Mellitus (T2DM)

In brief

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.

Key facts

Study ID

NCT07414277

Run by

Shanghai 6th People's Hospital

People needed

160

Starts

2026-05-11

Expected to finish

2027-12-31

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Current use of a real-time continuous glucose monitoring (RT-CGM) device, or use within the 3 months prior to enrollment.
• Severe skin disease at the sensor insertion site, or allergy to adhesive tape/adhesives.
• Pregnant women; positive pregnancy test at screening; or planning pregnancy during the study period.
• Currently participating in, or planning to participate in, another clinical trial.
• Current use of oral corticosteroid therapy, or anticipated use during the trial period.
• Severe liver disease, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN).
• Severe renal impairment or end-stage renal disease, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
• 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.

Where it is running

• Shanghai 7th People's Hospital — Shanghai, China (enrolling)
• Shanghai 6th People's Hospital — Shanghai, China (enrolling)
• Shanghai Fengxian District Central Hospital — Shanghai, China (enrolling)
• Shanghai General Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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