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Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups

Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups - Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039484
Enrollment
106
Registered
2020-02-14
Start date
2020-02-14
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

The intervention group will use the diabetes self-management application for 48 weeks. The control group will use a paper-based diabetes management note for 48 weeks.

Sponsors

Yokohama City University Medical Center
Lead Sponsor
Urafune Kanazawa Internal Medicine Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Type 2 diabetic patients admitted to Yokohama City Medical Center, Department of Endocrinology and Diabetes 2.Patients who can go to the Urafuna Kanazawa Internal Medicine Clinic, a joint research institution, after the last visit to our hospital 3.Patients who are receiving insulin or GLP-1 injection therapy and measuring their blood glucose 4.Patients who have been using a smartphone for more than 6 months 5.Patients aged 20 to under 75

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes 2.Patients with cancer currently undergoing treatment (can be included if follow-up during remission) 3.Patients with severe renal dysfunction (eGFR <30 ml / min / 1.73 m2) 4.Patients with severe liver dysfunction (AST and/or ALT >3x upper limit of normal) 5.Patients with severe infections or severe trauma 6.Patients using steroids(oral/injectable) 7.pregnancy 8.Patients who do not have a home blood pressure monitor 9.Patient with pacemaker 10.Patients judged by the investigator to be ineligible for some other reason

Design outcomes

Primary

MeasureTime frame
The difference of changes in HbA1c 24 weeks after the last outpatient visit at our hospital before referral

Secondary

MeasureTime frame
The Difference of changes in HbA1c 48 weeks after the last outpatient visit at our hospital before referral The Difference of changes in next items between baseline and 24, 48 weeks. 1.DTSQ 2.Systolic blood pressure 3.Diastolic blood pressure 4.Triglyceride 5.HDL-C 6.LDL-C 7.Body weight 8.Outpatient interruption 9.Referral to the main institution due to poor glycemic control 10.Muscle mass for body composition analysis 11.Fat content in body composition analysis

Countries

Japan

Contacts

Public ContactMasahiro Ichikawa

Yokohama City University Medical Center Department of Endocrinology and Diabetes

t196009c@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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