Type 2 diabetes
Conditions
Interventions
160 participants will be randomly classified into two groups, 80 in the DialBetesPlus group and 80 in the non-DialBetesPlus control group. Participants in the DialBetesPlus group will use the system f
Sponsors
Department of Healthcare Information Management, The University of Tokyo Hospital
Kawasaki Medical School(Academic juridical person, Kawasaki Gakuen.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: type 2 diabetes HbA1c>=6.5% BMI>=22 DM nephropathy stage 2 (morning urine albumin/creatinine ratio: 30-299mg/gCr) eGFR>=45 mL/min/1.73m2 BP< 180/110mmHg Age:20-74y no previous history of severe hypoglycemia. without history of suspect of hypoglycemia in the most recent 3 months. with voluntary written consent for participation in this study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of morning urine albumin/creatinine ratio between two points: start and end of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKana Miyake
the University of Tokyo Department of Healthcare Information Management, The University of Tokyo Hospital
Outcome results
None listed