NCT04932928

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study. It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin. Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.

Conditions

• Diabetes Mellitus, Type 2
• Lifestyle Risk Reduction

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre	Flash glucose monitoring + Education on lifestyle modification
DEVICE	Blood glucose meter	Self monitoring of blood glucose + Education on lifestyle modification

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-09-23
• Completion: 2023-03-23
• First posted: 2021-06-21
• Last updated: 2021-06-21

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study