Diabetes Mellitus, Type 2
Conditions
Keywords
Continuous Glucose Monitoring
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.
Interventions
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (3.9~10.0mmol/L, %) | 12 weeks | Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (3.9~10.0mmol/L, %) | 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. |
| Time above range (>10.0mmol/L, %) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM. |
| Time below range (<3.9mmol/L, %) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM. |
| Coefficient of variation (CV) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Standard deviation divided by mean glucose level measured by CGM. |
| HbA1c (%) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Glycated hemoglobin (%) |
| Mean amplitude of glycemic excursions (MAGE) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions. |
| Diabetes management self-efficacy | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | The Chinese version of Diabetes Management Self-efficacy Scale (DMSES) is used to evaluate the patients' self-efficacy |
| Diabetes Self Care Activities | 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 |
| Standard deviation (SD) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks | Standard deviation of blood glucose measurements during CGM. |
Countries
China
Contacts
Primary ContactShiyun Wang, Dr.
Outcome results
None listed