Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy

Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy - Safety evaluation of DialBetics for type 2 diabetes patients with insulin therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018649

Enrollment

Registered

2015-08-12

Start date

2015-08-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

To support self-management with DialBetics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients with insulin therapy. Patients who answered our previous intention survey and expressed to participate in this study. Patients who can use measuring devices (glucose meter, blood pressure monitor, weight scale, pedometer, urinary Na/K scan) and smartphone, who are considered to be eligible by the doctor. Patients without retinopathy or with simple retinopathy. Plasma creatinine level is less than 1.5 mg/dL. Patients who provided written informed consent.

Exclusion criteria

Exclusion criteria: Patients with mental illness. Patients with pacemakers. Patients who are enrolled in other clinical trials. Patients who have/had moderate to severe (requiring medical care) heart disease. Patients who have moderate to severe (unstable condition) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease. Patients who are unable to exercise. Patients who are under special dietary therapy (e.g. protein restriction, potassium restriction). Female patients who are breast-feeding or have possibility (hope) of pregnancy. Patients who are considered ineligible by the doctor.

Design outcomes

Primary

Measure	Time frame
Presence or absence of adverse events and hypoglycemia(< 40 mg/dL) after one month intervention	—

Secondary

Measure	Time frame
answer of use intention survey / physical data (height, body weight, BMI, blood pressure, visceral fat area) / input data during the study (physical activity, food intake, exercise record) / clinical laboratory results (fasting blood glucose, HDL cholesterol, LDL cholesterol, triglyceride, urinary protein, urinary microalbumin, urinary electrolytes)/ oral medicine / urinary sodium to potassium ratio / data of 24 hour food recall / answer of pre- and post-study interview survey	—

Measure

Time frame

answer of use intention survey / physical data (height, body weight, BMI, blood pressure, visceral fat area) / input data during the study (physical activity, food intake, exercise record) / clinical laboratory results (fasting blood glucose, HDL cholesterol, LDL cholesterol, triglyceride, urinary protein, urinary microalbumin, urinary electrolytes)/ oral medicine / urinary sodium to potassium ratio / data of 24 hour food recall / answer of pre- and post-study interview survey

—

Countries

Japan

Contacts

Public ContactKayo Waki

the University of Tokyo Department of Ubisuitous Health Informatics, Graduate School of Medicine

kwaki-tky@umin.ac.jp03-5800-9129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026