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

NCT06591286 | Recruiting DMC

• 1 other identifier: RT20240903
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• HbA1c (%)

  4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

• Time in range (3.9~10.0mmol/L, %)

  4weeks, 8weeks, 24weeks, 48 weeks

• Time above range (>10.0mmol/L, %)

  4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

• Time below range (<3.9mmol/L, %)

  4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

• Coefficient of variation (CV)

  4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

RT-CGM DEVICE

This group of patients will wear RT-CGM for blood glucose monitoring for three months.

Intervention group

SMBG DEVICE

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.

Control 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:

• years old ≤ age ≤ 80 years old.
• Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
• % ≤ HbA1c ≤ 12% in the last 1 month.
• Insulin therapy within 1 month of planned discharge from hospital.
• 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.
• Willing and able to provide written informed consent and comply with the requirements of this study.

You may not qualify if:

• Oral steroid hormone therapy.
• Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
• Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
• Patients with severe kidney injury or end-stage renal disease (eGFR \< 30 mL/min/1.73 m2).
• 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.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

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, Dr.

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyun Wang, Dr.

CONTACT

+86 21 2405 8570; rhyme2008@alumni.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: Professor, Chief Physician, Deputy Director, Department of Endocrinology and Metabolism

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: October 25, 2024
• Primary Completion: March 10, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)