CGM for Insulin-Treated T2DM During Post-Discharge Transition (TRANSIT-CGM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Device: RT-CGM; Device: SMBG

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhou; Phone Number: 86-21-64369181; Email: zhoujian@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China
    • Shanghai General Hospital
    • Contact: Yufan Wang; Phone Number: 86+13761675784; Email: yyffwang@sina.com
  • Shanghai, China
    • Shanghai 6th People's Hospital
    • Contact: Jian Zhou; Phone Number: 86-21-64369181; Email: zhoujian@sjtu.edu.cn
  • Shanghai, China
    • Shanghai Fengxian District Central Hospital
    • Contact: Peihong Chen; Phone Number: 86+18018820016; Email: cph502@163.com
  • Shanghai, China, 200137
    • Shanghai 7th People's Hospital
    • Contact: Xiaohua Li; Phone Number: 021-58670561; Email: 13816805177@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (RT-CGM Group); 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.	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.
Active Comparator: Control Group (SMBG Group); 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.	Device: SMBG; SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between change in HbA1c between the intervention group and the control group at Week 12	HbA1c, expressed as %	from baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between change in HbA1c between the intervention group and the control group at Week 24	HbA1c, expressed as %	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	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	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	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	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).	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).	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).	from baseline to Week 12 and Week 24

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Fengxian District Central Hospital; Shanghai 7th People's Hospital
• Investigators: Principal Investigator: Jian Zhou, Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; insulin-treated
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20260203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No