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

JRCT ID: jRCTs052180079

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity disease, impaired glucose tolerance (IGT) and type 2 diabetes
• Date of first enrollment: 11/06/2018
• Target sample size: 40
• Countries of recruitment: nothing,Japan
• Study type: Interventional
• Intervention(s): 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 regimen under the guidance of a nutritionist and a physician , and the other will continue the aforementioned diet and exercise regimen (control group). The FreesStyle Libre will be changed every two weeks and worn for six months. The control group will also wear the Libre Pro, a retrospective CGM, for 2 weeks after the first visit and for 2 weeks starting 1 month before the last visit in order to obtain blood glucose variability data.

Outcome(s)

• Primary Outcome: The difference in body weight between Visit 1, at the start, and Visit 5, 6 months later

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: hirota yushi
• Secondary ID(s): UMIN000028500