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NCT Number: NCT07414277

CGM for Insulin-Treated T2DM During Post-Discharge Transition

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 6th People's Hospital, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

SMBG

Device

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

Primary outcomes

  1. 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 %

Secondary outcomes

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

    Time frame: from baseline to Week 24

    HbA1c, expressed as %

  2. 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

    Percent

  3. 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

    Percent

  4. 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

    percent

  5. 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

    percent

  6. 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

    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).

  7. 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

    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).

  8. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Collaborators

  • Shanghai 7th People's Hospital
  • Shanghai Fengxian District Central Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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