UMIN-CTR Clinical Trial

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