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

JRCT ID: jRCT2032230521

Registered date:20/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 16/02/2024
• Target sample size: 240
• Study type: Interventional

Intervention(s)

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.
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.
The 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.

Outcome(s)

• Primary Outcome: Change from baseline in HbA1c at Week 24 (central lab measurement)

Secondary Outcome

o Change from baseline in HbA1c at each evaluation point (except Week 24) (central lab measurement)
o Achievement rate of HbA1c <8.0% at Week 24 in participants with baseline value >=8.0% (central lab measurement)
o Change from baseline value in fasting blood glucose and fasting insulin at Week 24 (central lab measurement)
o Percentage of participants who reduced their diabetes medication by Week 24 from baseline
o Percentage of participants who increased doses of diabetes medication or initiated hypoglycemic medication by Week 24 from baseline
o Change from baseline in HbA1c at each evaluation point during the follow-up period(central lab measurement)
o Change from Week 24 in HbA1c at each evaluation point during the follow-up period (central lab measurement)
o Percentage of participants who reduced their diabetes medication by Week 12 of the follow-up period from Week 24
o Percentage of participants who increased doses of diabetes medication or initiated hypoglycemic medication by Week 12 of the follow-up period from Week 24
o AEs, device deficiency, laboratory test results (hematology, biochemistry, and urinalysis), vital signs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participant has been diagnosed with type 2 diabetes for at least 12 weeks (84 days) at visit 1.
2. Participant being treated with diet and exercise therapy alone or hypoglycemic medications other than insulin in addition to diet and exercise therapy, who have been on the same therapy for at least 12 weeks (84 days) at visit 1.
3. Participant is considered to have room for improvement in diabetes self-management, including the conduct of diet and exercise therapy, and is willing to improve their diabetes self-management in compliance with the requirements for use of BAP0527 and blood glucose meter (visit 1).
4. Participant is considered to be manageable outpatiently during the study participation (visit 1).
5. Participant has no problem with cognitive function, visual acuity and ability to operate devices in entering data to BAP0527 and using a blood glucose meter (visit 1).
6. Participant who has a smartphone device and have been using it continuously at visit 1. The device must meet the following operating system requirements:
- iOS: version 13 and above
- Android: version 10 and above
7. Participant with HbA1c (central lab measurement) 8.0 percentage to 10.0 percentage at visit 1.
8. Participant who meets inclusion criteria 2-6 also at visit 2.
9. Female participants:
o Female participant is eligible to participate if she is not pregnant and one of the following conditions applies:
- Not a Women of Childbearing Potential (WOCBP)
- A WOCBP who has a negative urine or serum pregnancy test from the time of informed consent to visit 2 and agrees to follow the contraceptive guidance from the time of informed consent to the end of the follow-up period.
o Female participant must agree not to breastfeed from the time of informed consent to the end of the follow-up period.
10. Participant agrees not to participate in another interventional study while participating in this study.

Exclude criteria

1. Participant has been diagnosed with diabetes other than type 2 diabetes, such as type 1 diabetes and secondary diabetes.
2. Participant with a history of or undergoing treatment for diabetic ketoacidosis.
3. Participant with diabetic proliferative retinopathy (except for those who have undergone photocoagulation and whose symptoms are stable).
4. Participant has been diagnosed with clinically significant cardiovascular or cerebrovascular diseases within 12 weeks (84 days) prior to visit 1 (including the day of visit 1), such as myocardial infarction, uncontrolled angina/coronary artery disease, significant ventricular arrhythmias and heart failure (New York Heart Association class III/IV).
5. Participant with chronic diseases requiring continuous use (internal, injection, etc.) of systemic corticosteroids and/or immunosuppressive agents.
6. Participant with a malignant tumor (recurrence-free period less than 5 years).
7. Participant with serious infections.
8. Participant with serious liver disorder.
9. Participant with drug addiction, alcoholism, or unstable psychiatric illness.
10. Participant who is using insulin preparations.
11. Participant planning to be hospitalized or undergo surgery during the study period.
12. Participant who has previously been assigned to study treatment in this study.
13. Participant has received some study treatment (including the follow-up period) within 12 weeks (84 days) prior to visit 1 (including the day of visit 1) or within 5 times the half-life of the treatment at Week 12 (84 days) prior to visit 1.
14. Participant who has used a mobile app for the purpose of managing or assisting in the management of diabetes within 12 weeks (84 days) prior to visit 1 (including the day of visit 1) and has been determined that such past use affects the efficacy evaluation of this study.
15. Participant with a difference of >1.0 percentage between the highest and lowest HbA1c values (in-hospital measurement) measured within 12 weeks (84 days) prior to visit 1 (including the day of visit 1).
16. Participant with sitting systolic blood pressure (SBP) at rest >180 mmHg or sitting diastolic blood pressure (DBP) at rest >110 mmHg at least either visit 1 or Visit 2, or participant with sitting SBP at rest >160 mmHg or sitting DBP at rest >100 mmHg at both visit 1 and visit 2.
17. Participant with stage 3 or later diabetic nephropathy (estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73m^2 or urinary albumin of 300 mg/gCre or more; both values from the central lab measurement at visit 1).
18. Participant who owns and uses a smartphone device that may not properly display BAP0527 application, or participant who plans to replace his/her smartphone to such a device during the period from the time of informed consent to the end of the treatment period.
19. Participant is an employee of Astellas Group, Welldoc, Inc., Roche DC Japan K.K., relevant CROs or participating medical institutions.
20. Participant has any condition makes the participant unsuitable for study participation.

Related Information

• Primary Sponsor: Yamada Emi