Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
continuous glucose monitoring, insulin-treated
Brief summary
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
Sponsors
Shanghai 6th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Fengxian District Central Hospital
Shanghai 7th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between change in HbA1c between the intervention group and the control group at Week 12 | from baseline to Week 12 | HbA1c, expressed as % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between change in HbA1c between the intervention group and the control group at Week 24 | from baseline to Week 24 | HbA1c, expressed as % |
| 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 | Percent |
| 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 | Percent |
| 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 | percent |
| 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 | percent |
| 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 | Measured by Diabetes Management Self-efficacy Scale (DMSES) ；Total score ranges from 0 to 200 (0 to 10 per item across 20 items)；Higher scores mean: A better outcome (indicating higher self-efficacy in managing diabetes). |
| 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 | Measured by the Diabetes Distress Scale (DDS)；Total score ranges from 17 to 102 (1 to 6 per item across 17 items)；Higher scores mean: A worse outcome (indicating higher levels of diabetes-related distress). |
| 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 | Measured by the Glucose Monitoring Satisfaction Scale (GMSS), Version: Type 2 Diabetes；Total score ranges from 15 to 75 (1 to 5 per item across 15 items)；Higher scores mean: A better outcome (indicating higher satisfaction with glucose monitoring). |
Countries
China
Contacts
CONTACTJian Zhou
PRINCIPAL_INVESTIGATORJian Zhou
Shanghai 6th People's Hospital
Outcome results
None listed