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

Last updated: November 26, 2024
Sponsor: Shanghai 6th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

RT-CGM

SMBG

Clinical Study ID

NCT06591286
RT20240903
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofreal-time continuous glucose monitoring system in the 3 months prior tohospitalisation.

  6. Willing and able to provide written informed consent and comply with therequirements of this study.

Exclusion

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 glutamineaminotransferase 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/1.73m2).

  5. Participants were unable to tolerate tape adhesive around sensor placement area, orwith medically documented allergy towards the adhesive (glue) of plasters, or withserious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) aroundsensor placement area.

  6. Mental condition rendering the subject unable to understand the nature, scope, andpossible consequences of the study.

  7. Pregnant, breastfeeding, women of childbearing age who are unwilling to usecontraception during the study period.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: RT-CGM
Phase:
Study Start date:
October 25, 2024
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai 200233
    China

    Active - Recruiting

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