Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RT-CGM, SMBG.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device RT-CGM
This group of patients will wear RT-CGM for blood glucose monitoring for three months. - 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.
Primary outcome measures
- Time in range (3.9~10.0mmol/L, %) [Time frame: 12 weeks]
Secondary outcome measures (9)
- HbA1c (%) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Time in range (3.9~10.0mmol/L, %) [Time frame: 4weeks, 8weeks, 24weeks, 48 weeks]
- Time above range (>10.0mmol/L, %) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Time below range (<3.9mmol/L, %) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Coefficient of variation (CV) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Standard deviation (SD) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Mean amplitude of glycemic excursions (MAGE) [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Diabetes management self-efficacy [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
- Diabetes Self Care Activities [Time frame: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai 6th People's Hospital — Shanghai
Identifiers
NCT: NCT06591286 · RT20240903