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

NCT04932928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-06-21

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Lifestyle Risk Reduction

Interventions

DEVICE

FreeStyle Libre

Flash glucose monitoring + Education on lifestyle modification

DEVICE

Blood glucose meter

Self monitoring of blood glucose + Education on lifestyle modification

Sponsors & Collaborators

  • Inje University

    collaborator OTHER

  • Kangbuk Samsung Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Young Min Cho, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-09-23
Completion
2023-03-23
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04932928 on ClinicalTrials.gov