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

NCT06156696 | Completed Results

• 2 other identifiers: 0527-CL-0002jRCT2032230521
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus (T2DM); BAP0527; Blood Glucose Meter; Diabetes treatment support system; Digital health product; Self-monitoring of blood glucose (SMBG)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c Level at Week 24

  The change from Baseline in HbA1c level at Week 24 (central lab measurement) was defined by the formula: HbA1c level at Week 24 - HbA1c level at Baseline. A negative change indicated a reduction/improvement from Baseline (i.e. a favorable outcome). If the HbA1c level at Week 24 was missing, the analysis was conducted using an MMRM under the assumption that data were missing at random (MAR).

  Baseline and Week 24

Secondary Outcomes (12)

• Change From Baseline in HbA1c Level at Each Assessment Timepoint (Except Week 24)

  Baseline and Weeks 4, 8, 12, 16, and 20

• Percentage of Participants With a Baseline HbA1c Level ≥ 8.0% Who Achieved an HbA1c Level < 8.0% at Week 24

  Week 24

• Change From Baseline Value in Fasting Blood Glucose Level at Week 24

  Baseline and Week 24

• Change From Baseline Value in Fasting Insulin Level at Week 24

  Baseline and Week 24

• Percentage of Participants With a Decreased Dose of Antidiabetics or Reduced Number of Antidiabetics by Week 24, Relative to Antidiabetic Use at Baseline

  Baseline up to Week 24

Study Arms (2)

BAP0527 group

EXPERIMENTAL

Participants use the BAP0527 and Blood Glucose Meter in addition to the usual treatment at each site.

Device: BAP0527; Device: Blood Glucose Meter

Usual treatment group

NO INTERVENTION

Participants receive the usual treatment they received before participating in the study.

Interventions

BAP0527 DEVICE

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.

BAP0527 group

Blood Glucose Meter DEVICE

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

Also known as: ACCU-CHEK® Guide Me

BAP0527 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \</=10.0% (central lab measurement) as of visit 1.
• 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.
• Female participant is consenting not to breastfeed from the time of providing informed consent until the end of the follow-up period.
• Participant agrees not to participate in another interventional study while participating in the present study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Shiraiwa medical clinic

Kashiwara-shi, Osaka, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Transparency
• Organization: Astellas Pharma Inc.

astellas.resultsdisclosure@astellas.com

+81 3-3244-6500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 5, 2023
• Study Start: February 16, 2024
• Primary Completion: July 2, 2025
• Study Completion: September 10, 2025
• Last Updated: September 30, 2026
• Results First Posted: September 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)