Effect of Weight Loss using FreeStyle Libre in Obesity Patients with Impaired Glucose Tolerance (IGT) or Mild Diabetes: A randomized clinical trial

Not Applicable

• Conditions: Obesity disease, impaired glucose tolerance (IGT) and type 2 diabetes

• Registration Number: JPRN-jRCTs052180079
• Lead Sponsor: hirota yushi

Brief Summary

In this study, we conducted the world's first multicenter randomized controlled study to investigate the effect of visualization of blood glucose changes by FreeStyle Libre on obese patients with IGT or mild diabetes mellitus. No weight loss was observed in obese patients with IGT or diabetes mellitus. On the other hand, they found a significant decrease in glycemic variability indices.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Study Completion: 2021-02-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Patients who meet all of the following criteria will be considered
1. Patients who are at least 20 years of age at the time consent is obtained
2. Obese patients with a BMI of 25 kg/m2 or greater who meet the diagnostic criteria for IGT at 75gOGTT or diabetic patients with an HbA1c of 7.0% or less who are not using oral hypoglycemic agents.
3. any gender
4. outpatient
5. Patients who have given their free written consent to participate in the study

Exclusion Criteria

Patients applicable to even one of the following are excluded
1. Patients participating in other clinical studies
2. Patients with severe skin disease on the upper arm
3. Patients using other implantable medical devices such as pacemakers
4. Other patients judged inappropriate by the doctor in charge of this study
5. Among patients diagnosed with IGT, BMI of 25 kg / m 2 or more and less than 30 kg/m2, dyslipidemia or Patients who do not have hyperuricemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified