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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose. Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 19-80 - Diagnosed with type 2 diabetes mellitus (DM) - Uncontrolled type 2 DM: HbA1c 7.0-10.0% - Signed willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

FreeStyle Libre

Flash glucose monitoring + Education on lifestyle modification

DEVICE

Blood glucose meter

Self monitoring of blood glucose + Education on lifestyle modification

Locations (1)

Seoul National University Hospital
Seoul, South Korea