Effects of Continuous Glucose Monitoring on Patients With Type 2 Diabetes Treated With Insulin During Post-Discharge Transition: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Difference between change in HbA1c between the intervention group and the control group at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: RT-CGM (Device)
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.
干预措施: SMBG (Device)
结局指标
主要结局
Difference between change in HbA1c between the intervention group and the control group at Week 12
时间窗: from baseline to Week 12
HbA1c, expressed as %
次要结局
- Difference between change in HbA1c between the intervention group and the control group at Week 24(from baseline to Week 24)
- Difference in CGM Time in Range (TIR) (3.9-10.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26(at Week 14 and Week 26)
- Difference in CGM Time Above Range (TAR) (>10.0 mmol/L; >13.9 mmol/L) between the intervention group and the control group at Week 14 and Week 26(at Week 14 and Week 26)
- Difference in CGM Time Below Range (TBR) (<3.9 mmol/L; <3.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26(at Week 14 and Week 26)
- Difference in CGM coefficient of variation (CV) between the intervention group and the control group at Week 14 and Week 26(at Week 14 and Week 26)
- Difference between change in self-efficacy score between the intervention group and the control group at Week 12 and Week 24(from baseline to Week 12 and Week 24)
- Difference between change in diabetes-related distress between the intervention group and the control group at Week 12 and Week 24(from baseline to Week 12 and Week 24)
- Difference between change in glucose monitoring satisfaction between the intervention group and the control group at Week 12(from baseline to Week 12 and Week 24)
研究者
Jian Zhou
Principal Investigator, Professor, Chief Physician, Director
Shanghai 6th People's Hospital