Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jun 13, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how using a device called FreeStyle Libre can help people with type 2 diabetes improve their health by making lifestyle changes. Participants will be randomly assigned to either use the FreeStyle Libre device for 12 weeks or be in a control group without the device. The main goal is to see if using this device helps lower the average blood sugar levels, measured by a test called HbA1c, in patients who are already on specific diabetes medications.

To join the study, you need to be between 19 and 80 years old and have been diagnosed with type 2 diabetes that is not well controlled (with HbA1c levels between 7.0% and 10.0%). You should also be able to provide your agreement to participate. However, if you have other types of diabetes, are pregnant, or have certain health conditions, you may not be eligible. If you decide to participate, you will be monitored closely, and this could provide you with valuable insights into managing your diabetes better.

Gender

ALL

Eligibility 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