UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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
Acronym
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
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Type 2 Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of changes in HbA1c 24 weeks after the last outpatient visit at our hospital before referral
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will use the diabetes self-management application for 48 weeks.
Interventions/Control_2
The control group will use a paper-based diabetes management note for 48 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
232-0024
Address
4-57 Urahune-cho, Minami-ku, Yokohama, 232-0024, Japan
TEL
045-261-5656
Naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ichikawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
232-0024
Address
4-57 Urahune-cho, Minami-ku, Yokohama, 232-0024, Japan
TEL
045-261-5656
Homepage URL
t196009c@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
H2 Incorporated
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Urafune Kanazawa Internal Medicine Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
0453707627
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045022
