CGM for Insulin-Treated T2DM During Post-Discharge Transition

NCT07414277 | Not Yet Recruiting

• 1 other identifier: 20260203
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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. 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)

Keywords

continuous glucose monitoring; insulin-treated

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Difference between change in HbA1c between the intervention group and the control group at Week 24

  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

  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

  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

  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

  at Week 14 and Week 26

Study Arms (2)

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.

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.

Device: SMBG

Interventions

RT-CGM DEVICE

RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.

Intervention group (RT-CGM Group)

SMBG DEVICE

SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.

Control Group (SMBG Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shanghai Fengxian District Central Hospital: collaborator

Study Sites (4)

Shanghai 6th People's Hospital

Shanghai, China

Location

Shanghai Fengxian District Central Hospital

Shanghai, China

Location

Shanghai General Hospital

Shanghai, China

Location

Shanghai Tongji Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jian Zhou

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou

CONTACT

86-21-64369181; zhoujian@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Chief Physician, Director

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)