RT-CGM
DeviceRT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
NCT Number: NCT07414277
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Shanghai 6th People's Hospital, Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.
Time frame: from baseline to Week 12
HbA1c, expressed as %
Time frame: from baseline to Week 24
HbA1c, expressed as %
Time frame: at Week 14 and Week 26
Percent
Time frame: at Week 14 and Week 26
Percent
Time frame: at Week 14 and Week 26
percent
Time frame: at Week 14 and Week 26
percent
Time frame: 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).
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Shanghai 6th People's Hospital
Other
Effects of Continuous Glucose Monitoring on Patients With Type 2 Diabetes Treated With Insulin During Post-Discharge Transition: A Multicenter Randomized Controlled Trial
Acronym: TRANSIT-CGM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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