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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052180079

Enrollment

Registered

2019-02-27

Start date

2018-06-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Patients will be divided into two groups: one will wear FreeStyle Libre for six months (intervention group) in addition to a diet regimen of 25 kcal per kilogram of standard body weight and exercise r

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The difference in body weight between Visit 1, at the start, and Visit 5, 6 months later	—

Secondary

Measure	Time frame
1. degree of improvement in glucose intolerance, HbA1c, blood pressure, serum lipids, serum uric acid level, serum transaminase level, change in dietary intake, change in health-related quality of life, and glycemic variability data assessed by OGTT after 6 months. 2. frequency of itching and skin rash at the site of FreeStyle Libre 3. lipid mediator levels before and 6 months after the intervention	—

Measure

Time frame

1. degree of improvement in glucose intolerance, HbA1c, blood pressure, serum lipids, serum uric acid level, serum transaminase level, change in dietary intake, change in health-related quality of life, and glycemic variability data assessed by OGTT after 6 months. 2. frequency of itching and skin rash at the site of FreeStyle Libre 3. lipid mediator levels before and 6 months after the intervention

—

Countries

Japan, nothing

Contacts

Public ContactSeiji Nishikage

Kobe University Hospital

nskg@med.kobe-u.ac.jp+81-783825861

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026