Clinical trial NCT06591286: Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Continuous Glucose Monitoring
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time in range (3.9~10.0mmol/L, %)
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c (%)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Time in range (3.9~10.0mmol/L, %)
timeFrame: 4weeks, 8weeks, 24weeks, 48 weeks
measure: Time above range (>10.0mmol/L, %)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Time below range (<3.9mmol/L, %)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Coefficient of variation (CV)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Standard deviation (SD)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Mean amplitude of glycemic excursions (MAGE)
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Diabetes management self-efficacy
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
measure: Diabetes Self Care Activities
timeFrame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Jian Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: