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COMPLETED
NCT06156696

A Study to Compare the Use of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Addition to Daily Practice and Treatment With Daily Practice and Treatment Alone in Patients With Type 2 Diabetes Mellitus

Sponsor: Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise are lifestyle-based, it is generally difficult to make lifestyle changes and continue self-management for diabetes management. The objective of this study is to determine whether the use of a diabetes treatment support system (BAP0527 and blood glucose meter, hereafter, this product) would allow type 2 diabetes mellitus patients to control their blood glucose well. BAP0527 is a modified Japanese version of BlueStar®, a smartphone application approved by the U.S. Food and Drug Administration to manage and support the treatment of diabetes in adults. The blood glucose meter is a device that measures blood glucose levels from fingertips and palm blood using a dedicated paracentesis device (a device used to draw blood). In this study, BAP0527 will be used in conjunction with the blood glucose meter. This study is open-label. Open-label means that subjects participating in this study are aware of whether they use this product in addition to their daily practice and treatment. Whether a subject uses this product or not is determined randomly. The subjects in the group using this product will be required to install BAP0527 on their smartphones and record their lifestyle habits (diet, exercise, sleep), medication compliance, blood pressure, pulse, weight, and also blood glucose levels measured by the blood glucose meter. In addition, they will review lifestyle habits according to the messages sent by BAP0527 based on the inputs, and watch educational contents. On the other hand, subjects in the group not using this product will continue to receive the treatment they have taken before participating in the study. The study period is approximately 10 months. During this period, a subject will visit a hospital approximately 12 times. For subjects in the group who use this product, the duration of use of this product is approximately 6 months. When a subject visits a hospital, a study doctor will confirm if the subject has a health problem. In addition, laboratory test, body temperature, blood pressure, and pulse will be confirmed. Blood/urine samples will be collected from subjects for laboratory tests.

Official title: Multicenter, Randomized, Open-label Study of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Patients With Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2024-02-16

Completion Date

2025-09-10

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DEVICE

BAP0527

Participants will continuously use BAP0527, while measuring their daily blood glucose levels using the blood glucose meter, and will input daily self-management records such as lifestyle habits (diet, exercise, sleep), use of medication and measurements (blood glucose level, blood pressure, pulse rate, body weight) into BAP0527.

DEVICE

Blood Glucose Meter

Participants measure blood glucose using a blood glucose meter in daily life.

Locations (1)

Shiraiwa medical clinic

Kashiwara-shi, Osaka, Japan