Recruiting

CGM for Insulin-Treated T2DM During Post-Discharge Transition

ClinicalTrials.gov IDNCT07414277

PhaseNA

Enrollment160

SponsorShanghai 6th People's Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM)

About this study

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.

Interventions

Device: RT-CGM — RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
Device: SMBG — SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.

Primary outcomes

Difference between change in HbA1c between the intervention group and the control group at Week 12 (from baseline to Week 12)

Eligibility information

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.

Study locations

Shanghai 7th People's Hospital, Shanghai, 200137 China
Shanghai 6th People's Hospital, Shanghai, China
Shanghai Fengxian District Central Hospital, Shanghai, China
Shanghai General Hospital, Shanghai, China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.