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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FreeStyle Libre
DeviceFlash glucose monitoring + Education on lifestyle modification
Blood glucose meter
DeviceSelf monitoring of blood glucose + Education on lifestyle modification
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: FreeStyle Libre (CGM) GroupExperimental treatment 1 intervention
Group B: Self Monitoring of Blood Glucose (SMBG) GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c
Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3
Time frame
Baseline to Month 3Secondary outcomes
1
Change in mean fasting glucose
Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3
Time frame
Baseline to Month 32
Change in body weight
Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3
Time frame
Baseline to Month 33
Change in blood pressure
Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3
Time frame
Baseline to Month 34
Change in waist circumference
Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3
Time frame
Baseline to Month 3Other outcomes
1
Change in CGM time in target range
Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group
Time frame
Baseline to Month 32
Change in CGM time-hyperglycemic
Change in CGM time in time above target range, defined as \>250 mg/dL from baseline to Month 3 in the CGM group
Time frame
Baseline to Month 33
Change in CGM time-hypoglycemic
Change in CGM time in time below target range, defined as \<70 mg/dL (level 1) and \< 54 (level 2) from baseline to Month 3 in the CGM group
Time frame
Baseline to Month 34
Change in CGM glucose variability
Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group
Time frame
Baseline to Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Inje University
Collaborator
Kangbuk Samsung Hospital
Collaborator
Source ClinicalTrials.gov