Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University Hospital
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.
Eligibility criteria
Qualifiers
Age 19-80
Diagnosed with type 2 diabetes mellitus (DM)
Uncontrolled type 2 DM: HbA1c 7.0-10.0%
Signed informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- FreeStyle Libre
- Blood glucose meter
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Inje University
Collaborator
Kangbuk Samsung Hospital
Collaborator
Source ClinicalTrials.gov