Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000033261
• Lead Sponsor: Department of Healthcare Information Management, The University of Tokyo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Study Completion: 2023-04-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with pacemakers. Patients with hyperthyroidism and under treatment(except for thyroid hormone replacement therapy) in the most recent 1 year. serum Albumin<3.0g/dl Hb<10.0g/dl Patients with preproliferative retinopathy or preproliferative retinopathy in the most recent 1 year. Patients who are enrolled in other clinical trials. Patients who have moderate to severe (requiring restriction on exercise therapy) heart disease. Patients who have moderate to severe (unstable condition and/or requiring restriction on exercise therapy) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease. Patients who are unable to exercise. Patients who are under protein restriction therapy Female patients who are breast-feeding or have possibility or hope of pregnancy. Patients who are considered ineligible by the doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction of morning urine albumin/creatinine ratio between two points: start and end of intervention.

Secondary Outcome Measures

Name	Time	Method
Changes in the following items will be compared between the intervention group and the conventional therapy group at the baseline and at 12 months (some items will be evaluated at 6 months and 18 months.) HbA1c, fasting plasma glucose, albuminuria (except for 12th month), eGFR, BMI, systolic and diastolic blood pressure, HDL-cholesterol, LDL-cholesterol, triglyceride, composite cardiovascular outcomes, all-cause deaths, composite renal end points, diets, self-management scores, medication therapy, QoL, and comparison in the operation of the trial between hospital model and pharmacy model. To ensure safety, we will monitor the number of hypoglycemic events, other adverse events, and troubles with the DialBetesPlus system over the course of the study.