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Feasibility study of a smartphone application in type 2 diabetes with stage 2 diabetic nephropathy

Feasibility study of a smartphone application in type 2 diabetes with stage 2 diabetic nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230674
Enrollment
15
Registered
2024-03-05
Start date
2024-03-05
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 with stage 2 diabetic nephropathy Type 2 diabetes mellitus, stage 2 diabetic nephropathy

Interventions

A newly developed smartphone application-based treatment program will be used for type 2 diabetes patients with stage 2 diabetic nephropathy.
education

Sponsors

Hirohito Sone
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients with type 2 diabetes 2. patients who use smartphones on a daily basis and are able to use the smartphone application included in this program to enter lifestyle-related data and take educational content. 3. patients with a recent urinary albumin level of 30 mg/g Cr or more and less than 300 mg/g Cr, or a urine albumin level of 30 mg/day or more and less than 300 mg/day within the first half year before consent is obtained 4. patients with an eGFR of 30 mL/min/1.73 m2 or greater within 6 months prior to obtaining consent 5. patients whose daily food intake (excluding snacks) is 3 times a day 6. patients who are at least 18 years old and less than 80 years old at the time of obtaining consent 7. patients with a recent HbA1c of 6.5% or more but less than 10% within the last year prior to obtaining consent

Exclusion criteria

Exclusion criteria: 1. patients with BMI less than 15 kg/m2 2. patients with cancer (malignant tumor (equivalent to C00-C97 in ICD-10 classification) that has not been cured within 5 years, or intraepithelial neoplasia (equivalent to D00-D09 in ICD-10 classification) that has not been cured within 1 year) 3. patients with hepatic impairment of Child-Pugh B or higher 4. pregnant or lactating patients 5. patients who are unable to enter lifestyle-related data into the smartphone application by themselves and require a proxy to do so 6. other patients whom the physician deems inappropriate

Design outcomes

Primary

MeasureTime frame
Two-sample test for change in HbA1c before and after treatment

Secondary

MeasureTime frame
Two-sample test will be conducted on the amount of change in the following items before and after treatment. Physical examination: blood pressure, BMI Blood and urine tests: LDL cholesterol, HDL cholesterol, triglycerides, creatinine, urinary albumin, eGFRQuestionnaire: ADDQoL, DTSQs and DTSQc will be compared Descriptive statistics on the following items during the treatment period Number of times the application is opened and recorded concerning weight, blood pressure, diet, other lifestyle habits

Contacts

Public ContactKitazawa Masaru

Niigata University Medical and Dental Hospital

m-kitazawa@med.niigata-u.ac.jp+81-25-368-9026

Outcome results

None listed

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