Actively Recruiting
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Led by Seoul National University Hospital · Updated on 2021-06-21
126
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
I
Inje University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 80 years
- Diagnosed with type 2 diabetes mellitus
- Uncontrolled type 2 diabetes with HbA1c between 7.0% and 10.0%
- Signed informed consent
You will not qualify if you...
- Diagnosed with other types of diabetes mellitus such as type 1 diabetes
- Use of prandial insulin
- Change in diabetes medication in the preceding 3 months
- Pregnant or lactating women
- Addiction to drugs or alcohol
- Use of medications causing drug-induced high blood sugar, such as steroids
- Severe liver disease
- End-stage renal disease requiring dialysis
- Unable to wear continuous glucose monitoring devices due to severe skin reactions or infections
- Conditions affecting the reliability of HbA1c measurements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 110-744
Actively Recruiting
Research Team
H
Hun Jee Choe, MD
CONTACT
Y
Young Min Cho, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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