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

JRCT ID: jRCTs032230674

Registered date:05/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus with stage 2 diabetic nephropathy
• Date of first enrollment: 05/03/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): A newly developed smartphone application-based treatment program will be used for type 2 diabetes patients with stage 2 diabetic nephropathy.

Outcome(s)

• Primary Outcome: Two-sample test for change in HbA1c before and after treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hirohito Sone
• Source(s) of Monetary Support: PBO Inc.,Japan Agency for Medical Research and Development