Exploratory clinical study on the smartphone application for type 2 diabetes

JRCT ID: jRCT1030220061

Registered date:11/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 18/05/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): In this study, the subjects are required to use the app daily for 12 weeks in principle. It is possible that the use of the app have a slight impact on medical care and change the doctor's response slightly. And behavior change could occur in the patient's self-management.

Outcome(s)

• Primary Outcome: Application usage rate and usage rate by recorded item

Secondary Outcome

Monthly changes in app usage
Questionnaire survey
Relationship between app input data and app usage rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

All of the following criteria must be met in order to participate in this study.
1) Patients who are visiting "Okamoto Clinic" or "Tomonaga Clinic" or "Mirai Clinic" ("the trial institutions") and who have obtained written informed consent.
2) Patients aged 20 to 65 years at the time of obtaining consent.
3) Patients scheduled to visit the trial institutions once a month.
4) Patients who, at the time of obtaining consent, have been diagnosed with type 2 diabetes for at least 12 weeks.
5) Patients with HbA1c value of 7.0% to 9.0% or less at the time of obtaining consent. (If HbA1c at the time of obtaining consent is not available, it is permitted to use HbA1c within 3 months from the time of obtaining consent.)
6) Patients who own iPhone and have been using it continuously for 12 weeks or more. (It is deemed that patients are using iPhone continuously, if they use it more than 4 days a week.)
7) Patients deemed by the investigator to be able to use the diabetes management program DRM01 ("the app").

Exclude criteria

Subjects were excluded based on 16 criteria:
1) Type 1 diabetes.
2) Secondary diabetes.
3) Patients receiving or planning to start intensive insulin therapy.
4) Patients with renal impairment. (eGFR less than 45 mL/min/1.73m2 or urinary microalbumin more than 300 mg/gCre)
5) Patients undergoing or planning to start hemodialysis.
6) Patients who have been diagnosed with dementia or are being treated for dementia.
7) Patients with experience requiring third-party intervention to treat hypoglycemia.
8) Patients with or need to have any exercise or dietary restrictions due to diseases other than diabetes.
9) Patients who have liver or cardiovascular diseases and are judged by the doctor to be difficult to participate in this study.
10) Patients with malignant tumors.
11) Patients with serious infections.
12) Patients who are dependent on alcohol or drugs, or have unstable psychiatric disorders and are deemed by the investigator to be inappropriate for this study.
13) Patients scheduled to be hospitalized or undergo surgery during the study period.
14) Patients who are pregnant, may be pregnant, or wish to be pregnant. (women only)
15) Patients who participated in other clinical trials in the 4 weeks prior to the consent of this study.
16) Patients deemed by the investigator to be inappropriate for this study.

Related Information

• Primary Sponsor: Eiji Arita