CGM for Insulin-Treated T2DM During Post-Discharge Transition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RT-CGM, SMBG.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Continuous Glucose Monitoring on Patients With Type 2 Diabetes Treated With Insulin During Post-Discharge Transition: A Multicenter Randomized Controlled Trial
Overview
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 outcome measures
- Difference between change in HbA1c between the intervention group and the control group at Week 12 [Time frame: from baseline to Week 12]
Secondary outcome measures (8)
- Difference between change in HbA1c between the intervention group and the control group at Week 24 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: from baseline to Week 12 and Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Shanghai 7th People's Hospital — Shanghai
- Shanghai 6th People's Hospital — Shanghai
- Shanghai Fengxian District Central Hospital — Shanghai
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT07414277 · 20260203