Unique ID issued by UMIN | UMIN000018649 |
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Receipt number | R000021596 |
Scientific Title | Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy |
Date of disclosure of the study information | 2015/08/12 |
Last modified on | 2018/02/21 10:30:00 |
Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy
Safety evaluation of DialBetics for type 2 diabetes patients with insulin therapy
Evaluation of safety of DialBetics, a smartphone based self-management support system for type 2 diabetes patients with insulin therapy
Safety evaluation of DialBetics for type 2 diabetes patients with insulin therapy
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To evaluate safety of DialBetics for type 2 diabetes patients with insulin therapy.
Safety,Efficacy
Presence or absence of adverse events and hypoglycemia(< 40 mg/dL) after one month intervention
answer of use intention survey / physical data (height, body weight, BMI, blood pressure, visceral fat area) / input data during the study (physical activity, food intake, exercise record) / clinical laboratory results (fasting blood glucose, HDL cholesterol, LDL cholesterol, triglyceride, urinary protein, urinary microalbumin, urinary electrolytes)/ oral medicine / urinary sodium to potassium ratio / data of 24 hour food recall / answer of pre- and post-study interview survey
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Educational,Counseling,Training
Other |
To support self-management with DialBetics
20 | years-old | <= |
75 | years-old | > |
Male and Female
Type 2 diabetes patients with insulin therapy.
Patients who answered our previous intention survey and expressed to participate in this study.
Patients who can use measuring devices (glucose meter, blood pressure monitor, weight scale, pedometer, urinary Na/K scan) and smartphone, who are considered to be eligible by the doctor.
Patients without retinopathy or with simple retinopathy.
Plasma creatinine level is less than 1.5 mg/dL.
Patients who provided written informed consent.
Patients with mental illness.
Patients with pacemakers.
Patients who are enrolled in other clinical trials.
Patients who have/had moderate to severe (requiring medical care) heart disease.
Patients who have moderate to severe (unstable condition) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease.
Patients who are unable to exercise.
Patients who are under special dietary therapy (e.g. protein restriction, potassium restriction).
Female patients who are breast-feeding or have possibility (hope) of pregnancy.
Patients who are considered ineligible by the doctor.
10
1st name | |
Middle name | |
Last name | Kayo Waki |
the University of Tokyo
Department of Ubiquitous Health Informatics, Graduate school of Medicine
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-5800-9129
kwaki-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Kayo Waki |
the University of Tokyo
Department of Ubisuitous Health Informatics, Graduate School of Medicine
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-5800-9129
kwaki-tky@umin.ac.jp
the University of Tokyo
NTT DOCOMO, INC. (The division is engaged in a cooperative program between the University of Tokyo and NTT DOCOMO.)
Profit organization
NO
東京大学医学部附属病院(東京都)、the University of Tokyo Hospital (Tokyo)
2015 | Year | 08 | Month | 12 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/27460625
DialBetics was found safe in data transmission, evaluation, and text communication for patients on insulin injections. Mean HbA1c (-0.26+/-0.27%, p=.014) and BMI (-0.41+/-0.56 kg/m2, p=.035) significantly decreased after one month.
Completed
2015 | Year | 07 | Month | 21 | Day |
2015 | Year | 08 | Month | 04 | Day |
2015 | Year | 08 | Month | 12 | Day |
2018 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021596
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