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

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.

Inclusion Criteria: * Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1. * Participants being treated with only diet and exercise therapy, or participants being treated with hypoglycemics other than insulin preparations in addition to diet and exercise therapy, who have continued the same treatment for at least 12 weeks (84 days) as of visit 1. * Participants who have potential for improvement from self-management of diabetes mellitus, including diet therapy and exercise therapy, and who are willing to improve their self-management of diabetes mellitus, while complying with the rules for participants relating to the use of BAP0527 and the blood glucose meter, as of visit 1. * Participants who are able to perform outpatient management while participating in this study, as of visit 1. * Participants have no problems inputting information into BAP0527 or using the blood glucose meter, from the perspective of cognitive function, visual acuity or device operating ability, as of visit 1. * Participants having and using a smartphone device meeting the following operating system requirements as of visit 1 * For iOS: Version 13 or later * For Android: Version 10 or later * Participants with an HbA1c level \>/=8.0% and \180 mmHg or diastolic blood pressure (DBP) \>110 mmHg at rest in a sitting position at either visit 1, visit 2 or both or participants with SBP\>160 mmHg or DBP \>100 mmHg at rest in a sitting position at both visit 1 and visit 2. * Participants with concurrent diabetic nephropathy of stage 3 or higher (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m\^2 or urinary albumin \>/= 300 mg/gCre \[each centrally measured values at visit 1\]). * Participants who have and use a smartphone device on which BAP0527 may not be displayed appropriately, or who plan to buy a new smartphone device on which BAP0527 may not be displayed appropriately between the time of providing informed consent and the end of the treatment period. * Participants who are employees of Astellas Group, Welldoc, Inc., Roche DC Japan K.K. or a study site, or the CRO involved in the study. * Participant has any condition, which makes the participant unsuitable for study participation.