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Clinical Trials in South Korea / NCT04932928
Recruiting Not applicable

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

NCT04932928 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2021-03-23
Last updated
2021-06-21

Condition(s) studied

Diabetes Mellitus, Type 2Lifestyle Risk Reduction

Investigational drug(s) / intervention(s)

FreeStyle LibreBlood glucose meter

FreeStyle Libre: Flash glucose monitoring + Education on lifestyle modification

Blood glucose meter: Self monitoring of blood glucose + Education on lifestyle modification

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in HbA1c — Baseline to Month 3
    Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04932928 on ClinicalTrials.gov ↗ ← All trials in South Korea