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
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Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1.
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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.
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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.
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Participants who are able to perform outpatient management while participating in this study, as of visit 1.
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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.
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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
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Participants with an HbA1c level >/=8.0% and </=10.0% (central lab measurement) as of visit 1.
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Participants who also meet inclusion criteria from the second to the sixth at visit 2.
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Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a Woman of Childbearing Potential (WOCBP)
- A WOCBP who has a negative urine or serum pregnancy test between the time of providing informed consent and visit 2 and agrees to follow the contraceptive guidance from the time of informed consent through the end of the follow-up period.
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Female participant is consenting not to breastfeed from the time of providing informed consent until the end of the follow-up period.
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Participant agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
- Participants diagnosed with a type of diabetes mellitus other than type 2 diabetes mellitus, such as type 1 diabetes mellitus or secondary diabetes mellitus.
- Participants with a history of, or currently receiving treatment for, diabetic ketoacidosis.
- Participants with retinopathy proliferative (however, if treatment such as photocoagulation has been performed and symptoms are stable, the participant may be enrolled).
- Participants diagnosed with clinically problematic cardiovascular or cerebrovascular disease such as myocardial infarction, poorly controlled angina pectoris/coronary artery disease, clinically problematic ventricular arrhythmia, cardiac failure (class III or IV according to the New York Heart Association classification) in the period of 12 weeks (84 days) before visit 1 (including the date of visit 1).
- Participants with chronic disease requiring continuous use (such as oral use or injection) of adrenocortical steroids or immunosuppressants for their systemic action.
- Participants with a concurrent malignant tumor (with a relapse-free period of less than 5 years).
- Participants with concurrent serious infection.
- Participants with concurrent serious hepatic disorder.
- Participants with drug addiction, alcohol dependence or unstable psychiatric disease.
- Participants using insulin preparations.
- Participants who plan to be hospitalized or receive surgery during the period of participants in this study.
- Participants who have already been assigned in this study.
- Participants who receive any study treatment (including a follow-up period) in the period of 12 weeks (84 days) before visit 1 (including the date of visit 1) or who participate in any study treatment, when 5 half-lives of this treatment have not elapsed as of 12 weeks (84 days) before visit 1.
- Participants who have used a mobile application operating on a smartphone device for managing, or assisting in the management of, diabetes mellitus in the 12 weeks (84 days) before visit 1 (including the date of visit 1), when judged that the possibility of this history of use affecting efficacy evaluation in this study cannot be ruled out.
- Participants with a difference of more than 1.0% in the maximum and minimum HbA1c levels (measured at the hospital) measured in the 12 weeks (84 days) before visit 1 (including the date of visit 1).
- Participants with systolic blood pressure (SBP) >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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
248 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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