CGM for Insulin-Treated T2DM During Post-Discharge Transition

N/ANot Yet RecruitingNCT07414277

Shanghai 6th People's Hospital160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (4)

Shanghai 6th People's Hospital

Shanghai, China

Shanghai Fengxian District Central Hospital

Shanghai, China

Shanghai General Hospital

Shanghai, China

Shanghai Tongji Hospital

Shanghai, China

Outcomes

Primary Outcomes

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 12

Secondary Outcomes

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 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

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

Percent

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

percent

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

percent

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

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).

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

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).

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

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).

Time frame: from baseline to Week 12 and Week 24

CGM for Insulin-Treated T2DM During Post-Discharge Transition

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts