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NCT Number: NCT06591286

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location status: Recruiting

Location contact

Shiyun Wang, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old ≤ age ≤ 80 years old.
  • Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
  • 8% ≤ 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.

Exclusion criteria

  • 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.

Treatment and study plan

RT-CGM

Device

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

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.

Primary outcomes

  1. Time in range (3.9~10.0mmol/L, %)

    Time frame: 12 weeks

    Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.

Secondary outcomes

  1. HbA1c (%)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Glycated hemoglobin (%)

  2. Time in range (3.9~10.0mmol/L, %)

    Time frame: 4weeks, 8weeks, 24weeks, 48 weeks

    Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.

  3. Time above range (>10.0mmol/L, %)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM.

  4. Time below range (<3.9mmol/L, %)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.

  5. Coefficient of variation (CV)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Standard deviation divided by mean glucose level measured by CGM.

  6. Standard deviation (SD)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Standard deviation of blood glucose measurements during CGM.

  7. Mean amplitude of glycemic excursions (MAGE)

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions.

  8. Diabetes management self-efficacy

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    The Chinese version of Diabetes Management Self-efficacy Scale (DMSES) is used to evaluate the patients' self-efficacy

  9. Diabetes Self Care Activities

    Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks

    The Chinese version of Summary of Diabetes Self Care Activities (SDSCA) is used to evaluate the patients' self-efficacy

Study contacts

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

Shiyun Wang, Dr.

CONTACT

[email protected]

+86 21 2405 8570

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Nov 29, 2024

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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