Type 2 Diabetes Mellitus (T2DM)TRANSIT-CGMNCT07414277
CGM for Insulin-Treated T2DM During Post-Discharge Transition
A study testing RT-CGM and SMBG in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai 6th People's Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- RT-CGM and SMBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- 11 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Shanghai 7th People's Hospital
Shanghai, 200137
Xiaohua Li, 021-58670561, 13816805177@163.com
- Recruiting
Shanghai 6th People's Hospital
Shanghai
Jian Zhou, 86-21-64369181, zhoujian@sjtu.edu.cn
- Recruiting
Shanghai Fengxian District Central Hospital
Shanghai
Peihong Chen, 86+18018820016, cph502@163.com
- Recruiting
Shanghai General Hospital
Shanghai
Yufan Wang, 86+13761675784, yyffwang@sina.com
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- RT-CGM, SMBG
- Keywords
- continuous glucose monitoring, insulin-treated
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-CGMDevice
RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
SMBGDevice
SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (RT-CGM Group) | Experimental | 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. Receives: Device: RT-CGM |
| Control Group (SMBG Group) | Active comparator | 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. Receives: Device: SMBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between change in HbA1c between the intervention group and the control group at Week 12
HbA1c, expressed as %
Measured: from baseline to Week 12
Secondary outcomes (8)
Difference between change in HbA1c between the intervention group and the control group at Week 24
HbA1c, expressed as %
Measured: 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
Percent
Measured: 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
Percent
Measured: 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
percent
Measured: 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
percent
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: from baseline to Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Fengxian District Central Hospital, Shanghai 7th People's Hospital
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
- Investigators
- Jian Zhou, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414277
- Sponsor's protocol ID
- 20260203
- Acronym
- TRANSIT-CGM
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07414277
- Acronym / sponsor ID
- TRANSIT-CGM / 20260203
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- continuous glucose monitoring, insulin-treated
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Fengxian District Central Hospital, Shanghai 7th People's Hospital
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (RT-CGM Group) | Experimental | Device: RT-CGMParticipants 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. |
| Control Group (SMBG Group) | Active comparator | Device: SMBGParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-CGMRT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts. | Device | Intervention group (RT-CGM Group) |
| SMBGSMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing. | Device | Control Group (SMBG Group) |
Primary outcome
Difference between change in HbA1c between the intervention group and the control group at Week 12
Time frame: from baseline to Week 12
HbA1c, expressed as %
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Zhou principal investigator
Shanghai 6th People's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-CGM and SMBG in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai 6th People's Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhou (86-21-64369181, zhoujian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between change in HbA1c between the intervention group and the control group at Week 12 (time frame: from baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.