CGM for Insulin-Treated T2DM During Post-Discharge Transition
Recruiting · NCT07414277 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai 6th People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Inclusion criteria
- 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).
Exclusion criteria
- 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
4 locations listed.
- Shanghai 7th People's Hospital - Shanghai, China
- Shanghai 6th People's Hospital - Shanghai, China
- Shanghai Fengxian District Central Hospital - Shanghai, China
- Shanghai General Hospital - Shanghai, China