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An open-label, randomized, parallel-group comparison study on the effects of the "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

An open-label, randomized, parallel-group comparison study on the effects of the "e-Diabetes Diary" on self-management efficacy for type 2 diabetics - Study on the effects of "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017719
Enrollment
30
Registered
2015-07-01
Start date
2015-07-01
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

30 Type 2 diabetics who use their smartphones daily

Interventions

The intervention group will be provided access to &quot
e-Diabetes Diary&quot
as well as instructions based on the web-service. On the first visit, patients will receive guidance on how to use the &quot
and the personal ID and password for access. Also, patients will be provided self-recording devices (digital-scale, digital pedometer, automated sphygmomanometer, self monitoring blood glucose meter)
. The patient will then be instructed to reference the &quot
in their self-treatment and record their progress according to the doctor&#39
s instructions for the next 3 months. The treatment goals, test results and assessments on diabetes and complications provided by the doctor will be recorded in the e-Diabetes Diary&quot
. The doctor will use the &quot
in consulting and providing guidance to the patient at each visit during the 3 months intervention. The control group will be provided standard care using the standard &quot
Diabetes Logbook&quot
issued by the Japan Association for Diabetes Education and Care. The control group will be offered self-recording devices (scale, pedometer, automated sphygmomanometer, self monitoring blood glucose m
for their self-treatment over the next 3 months. The doctor will note the treatment goals, test results and assessments on diabetes and complications in the &quot
. It will be use in consulting and providing guidance to the patient at each visi

Sponsors

Tokushima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Has been diagnosed with Type 2 Diabetes HbA1c(NGSP) is more than 6.0% Is a daily smartphone user Has given written consent to participate in the research

Exclusion criteria

Exclusion criteria: Those whose HbA1c has worsen by more than 1% over the last 3 months, and/or has failed to reach treatment goals and assessed to need immediate care. Those who are undergoing intensive cardio-vascular, cerebrovascular and kindney disease treatment. Those who are participating in other interventional clinical trials Those for other reasons, who have been assessed to be not fit by their doctor,

Design outcomes

Primary

MeasureTime frame
After receiving instructions from their doctor, patients will self-manage their diabetes using the "e-diabetes diary" for 3 months. At the end of 3 months, the changes in the patients' understanding and knowledge of their self-management activities will be measured by interview and questionnaire.

Secondary

MeasureTime frame
After receiving instructions from their doctor, patients will self-manage their diabetes using the "e-diabetes diary" for 3 months. At the end of 3 months, the following items will be measured. The changes in the patients' self-management activities will be measured by interview and questionnaire. The changes in diet will be measured by food frequency questionnaire. The changes in exercise will be measured using a pedometer. The changes in blood glucose level management will be assessed by measuring HbA1c. The changes in obesity level will be assessed by measuring weight, BMI and body composition. The changes in diabetes related complications will be assessed by measuring triglyceride, total cholesterol, HDL cholesterol, BUN, Creatinine, AST, ALT, urinary albumin excretion rate and e-GFR.

Countries

Japan

Contacts

Public ContactSatoshi Taniguchi

Tokushima University Diabetes Therapeutics and Research Center

satoshi.taniguchi@tokushima-u.ac.jp088-633-7587

Outcome results

None listed

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