Using FreeStyle Libre for lifestyle changes in type 2 diabetes patients
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
This study is testing if using the FreeStyle Libre continuous glucose monitor helps people with type 2 diabetes make better lifestyle changes compared to traditional blood sugar checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04932928 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Continuous Glucose Monitoring (CGM) using the FreeStyle Libre device compared to Self-Monitoring of Blood Glucose (SMBG) in patients with type 2 diabetes. The study will involve 126 participants who have an elevated HbA1c between 7.0 - 10.0% and are not using prandial insulin. Participants will receive personalized education on lifestyle modifications and will be monitored over a 12-week period to assess changes in their glycemic control. The study is randomized and open-label, with participants assigned to either the CGM or SMBG group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-80 diagnosed with uncontrolled type 2 diabetes mellitus and an HbA1c level between 7.0 - 10.0%.
Not a fit: Patients with other types of diabetes, those using prandial insulin, or individuals with severe skin conditions that prevent the use of CGM devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycemic control and lifestyle management for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results using CGM for diabetes management, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19-80 * Diagnosed with type 2 diabetes mellitus (DM) * Uncontrolled type 2 DM: HbA1c 7.0-10.0% * Signed informed consent Exclusion Criteria: * Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM) * Use of prandial insulin * Change in diabetes medication in the preceding 3 months * Pregnant/lactating women * Addiction to drugs and alcohol * Use of medications that result in drug-induced hyperglycemia (i.e. steroid) * Severe liver disease * End-stage renal disease (i.e. on dialysis) * Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.) * Conditions that impact the stability of HbA1c measurement
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Min Cho, MD, PhD — Seoul National University Hospital
- Study coordinator: Hun Jee Choe, MD
- Email: hunjeechoe@snu.ac.kr
- Phone: 82-2-2072-1965
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.