Unique ID issued by UMIN | UMIN000039484 |
---|---|
Receipt number | R000045022 |
Scientific Title | Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups |
Date of disclosure of the study information | 2020/02/14 |
Last modified on | 2020/08/17 13:39:07 |
Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups
Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups
Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups
Study on the effect of diabetes self-management application intervention in patients with type 2 diabetes after referral to a clinic: A randomized trial between parallel groups
Japan |
Type 2 Diabetes mellitus
Endocrinology and Metabolism |
Others
NO
The study aims to evaluate the effects of the diabetes self-management application in patients with type 2 diabetes who are using insulin or GLP-1 preparation injection therapy or concurrently and are performing self-measurement of blood glucose.
Safety,Efficacy
The difference of changes in HbA1c 24 weeks after the last outpatient visit at our hospital before referral
The Difference of changes in HbA1c 48 weeks after the last outpatient visit at our hospital before referral
The Difference of changes in next items between baseline and 24, 48 weeks.
1.DTSQ
2.Systolic blood pressure
3.Diastolic blood pressure
4.Triglyceride
5.HDL-C
6.LDL-C
7.Body weight
8.Outpatient interruption
9.Referral to the main institution due to poor glycemic control
10.Muscle mass for body composition analysis
11.Fat content in body composition analysis
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Other |
The intervention group will use the diabetes self-management application for 48 weeks.
The control group will use a paper-based diabetes management note for 48 weeks.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1.Type 2 diabetic patients admitted to Yokohama City Medical Center, Department of Endocrinology and Diabetes
2.Patients who can go to the Urafuna Kanazawa Internal Medicine Clinic, a joint research institution, after the last visit to our hospital
3.Patients who are receiving insulin or GLP-1 injection therapy and measuring their blood glucose
4.Patients who have been using a smartphone for more than 6 months
5.Patients aged 20 to under 75
1.Type 1 diabetes
2.Patients with cancer currently undergoing treatment (can be included if follow-up during remission)
3.Patients with severe renal dysfunction (eGFR <30 ml / min / 1.73 m2)
4.Patients with severe liver dysfunction (AST and/or ALT >3x upper limit of normal)
5.Patients with severe infections or severe trauma
6.Patients using steroids(oral/injectable)
7.pregnancy
8.Patients who do not have a home blood pressure monitor
9.Patient with pacemaker
10.Patients judged by the investigator to be ineligible for some other reason
106
1st name | Tadashi |
Middle name | |
Last name | Yamakawa |
Yokohama City University Medical Center
Department of Endocrinology and Diabetes
232-0024
4-57 Urahune-cho, Minami-ku, Yokohama, 232-0024, Japan
045-261-5656
Naibunpi@urahp.yokohama-cu.ac.jp
1st name | Masahiro |
Middle name | |
Last name | Ichikawa |
Yokohama City University Medical Center
Department of Endocrinology and Diabetes
232-0024
4-57 Urahune-cho, Minami-ku, Yokohama, 232-0024, Japan
045-261-5656
t196009c@yokohama-cu.ac.jp
Yokohama City University Medical Center
H2 Incorporated
Profit organization
Urafune Kanazawa Internal Medicine Clinic
Yokohama City University Certified Institutional Review Board
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
0453707627
rinri@yokohama-cu.ac.jp
NO
2020 | Year | 02 | Month | 14 | Day |
Unpublished
Terminated
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 02 | Month | 05 | Day |
2020 | Year | 02 | Month | 14 | Day |
2024 | Year | 09 | Month | 30 | Day |
2020 | Year | 02 | Month | 14 | Day |
2020 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045022