Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control

Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control and Self-efficacy Among Patients With Type 2 Diabetes Treated With Insulin

Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: RT-CGM; Device: SMBG

Detailed Description

Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.

One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyun Wang, Dr.; Phone Number: +86 21 2405 8570; Email: rhyme2008@alumni.sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Recruiting
      • Shanghai 6th People's Hospital
      • Contact: Shiyun Wang, PhD; Email: rhyme2008@alumni.sjtu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old.
2. Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
3. 8% ≤ HbA1c ≤ 12% in the last 1 month.
4. Insulin therapy within 1 month of planned discharge from hospital.
5. Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
6. Willing and able to provide written informed consent and comply with the requirements of this study.

Exclusion Criteria:

1. Oral steroid hormone therapy.
2. Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
3. Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
4. Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2).
5. Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
7. Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.

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; The intervention group (75 cases) will wear real-time CGM to monitor blood glucose for 12 weeks, followed by 36 weeks of follow-up.	Device: RT-CGM; This group of patients will wear RT-CGM for blood glucose monitoring for three months.
Other: Control group; The control group (75 cases) is self-monitored by traditional SMBG for 12 weeks at a frequency of no less than 4 times a week, followed by 36 weeks of follow-up.	Device: SMBG; This group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range (3.9~10.0mmol/L, %)	Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%)	Glycated hemoglobin (%)	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time in range (3.9~10.0mmol/L, %)	Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.	4weeks, 8weeks, 24weeks, 48 weeks
Time above range (>10.0mmol/L, %)	Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM.	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Time below range (<3.9mmol/L, %)	Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Coefficient of variation (CV)	Standard deviation divided by mean glucose level measured by CGM.	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Standard deviation (SD)	Standard deviation of blood glucose measurements during CGM.	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Mean amplitude of glycemic excursions (MAGE)	Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions.	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes management self-efficacy	The Chinese version of Diabetes Management Self-efficacy Scale (DMSES) is used to evaluate the patients' self-efficacy	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Diabetes Self Care Activities	The Chinese version of Summary of Diabetes Self Care Activities (SDSCA) is used to evaluate the patients' self-efficacy	4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Principal Investigator: Jian Zhou, Dr., Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): March 10, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 7, 2024
• First Submitted That Met QC Criteria: September 7, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RT20240903

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
• product manufactured in and exported from the U.S.: No