Using continuous glucose monitoring to improve blood sugar control after hospital discharge for diabetes patients
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
This study is testing whether using a continuous glucose monitor can help people with type 2 diabetes manage their blood sugar better after leaving the hospital compared to traditional blood sugar checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06591286 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of a real-time continuous glucose monitoring (RT-CGM) system compared to traditional self-monitoring of blood glucose (SMBG) in managing blood sugar levels for patients with type 2 diabetes who are discharged from the hospital. The study involves 150 insulin-treated adults who will be randomly assigned to either the RT-CGM or SMBG group for a 12-week intervention, followed by a 36-week follow-up period. The goal is to assess improvements in glycemic control and self-efficacy in managing diabetes post-discharge.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with type 2 diabetes who are insulin-treated and have not used continuous glucose monitoring in the past three months.
Not a fit: Patients with acute diabetes complications, severe liver or kidney disease, or those on oral steroid hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance blood glucose control and self-management for patients with type 2 diabetes after leaving the hospital.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring systems, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai 6th People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jian Zhou, Dr. — Shanghai 6th People's Hospital
- Study coordinator: Shiyun Wang, Dr.
- Email: rhyme2008@alumni.sjtu.edu.cn
- Phone: +86 21 2405 8570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.