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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 19-80

• Diagnosed with type 2 diabetes mellitus (DM)

• Uncontrolled type 2 DM: HbA1c 7.0-10.0%

• Signed informed consent

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Hun Jee Choe, MD
hunjeechoe@snu.ac.kr
82-2-2072-1965
Backup
Young Min Cho, MD, PhD
ymchomd@snu.ac.kr
82-2-2072-1965
Time Frame
Start Date: 2021-03-23
Estimated Completion Date: 2023-03-23
Participants
Target number of participants: 126
Treatments
Experimental: FreeStyle Libre (CGM) Group
Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification
Active_comparator: Self Monitoring of Blood Glucose (SMBG) Group
Device: Blood glucose meter Education on lifestyle modification
Related Therapeutic Areas
Sponsors
Collaborators: Kangbuk Samsung Hospital, Inje University
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov