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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039484
Receipt No. 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

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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
Email 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
Email t196009c@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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