CGM for Insulin-Treated T2DM During Post-Discharge Transition
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai 6th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
SMBG
DeviceSMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Intervention group (RT-CGM Group)Experimental treatment 1 intervention
Group B: Control Group (SMBG Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference between change in HbA1c between the intervention group and the control group at Week 12
HbA1c, expressed as %
Time frame
from baseline to Week 12Secondary outcomes
1
Difference between change in HbA1c between the intervention group and the control group at Week 24
HbA1c, expressed as %
Time frame
from baseline to Week 242
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
Percent
Time frame
at Week 14 and Week 263
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
Percent
Time frame
at Week 14 and Week 264
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
percent
Time frame
at Week 14 and Week 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai 6th People's Hospital
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Fengxian District Central Hospital
Collaborator
Shanghai 7th People's Hospital
Collaborator
Source ClinicalTrials.gov