UMIN-CTR Clinical Trial

Basic information
Public title	Support of diabetes Mellitus patient daily life -Patient Lifestyle is improved by community pharmacistS-
Acronym	Support of diabetes Mellitus patient daily life -Patient Lifestyle is improved by community pharmacistS-
Scientific Title	Support of diabetes Mellitus patient daily life -Patient Lifestyle is improved by community pharmacistS-
Scientific Title:Acronym	Support of diabetes Mellitus patient daily life -Patient Lifestyle is improved by community pharmacistS-
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate that the activity mass of diabetic patients is affected by lifestyle guidance by community pharmacists.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activity mass (consumption energy, count of steps, time of moderately intense walking)
Key secondary outcomes	PAID, HbA1c, TC, HDL-C, TG, weight, blood pressure, abdominal circumference, boundary length of lower leg, rate of antidiabetes drugs, rate of antihypertensive drugs use, rate of antihyperlipidemic drug use, fasting glucose level, AST, ALT, r-GTP, relationship between PAID and activity mass, relationship between HbA1c and activity mass

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Using only Mediwalk
Interventions/Control_2	Using Mediwalk and Smiledatavision
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) HbA1c >=9 % 2) Type 2 diabetes (no restriction of prescription medication) 3) Possible to prescribed blood sampling in hospitals 4) 20-years-old and above 5) Individuals capable of giving voluntary, informed consent in writing 6) Permission of sub-investigator (doctor)
Key exclusion criteria	) Using of walking intensity monitor over the past 3 months 2) Exercise contraindication 3) Participating in another clinical study 4) Pregnant or possibility of pregnancy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Matsushita
Organization	Kanazawa University
Division name	Faculty of Pharmacy, Institute of Medical, Pharmaceutical Sciences
Zip code	920-1192
Address	Kanazawa
TEL	0762344405
Email	matusita@p.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Matsushita
Organization	Kanazawa University
Division name	Faculty of Pharmacy, Institute of Medical, Pharmaceutical Sciences
Zip code	920-1192
Address	Kanazawa
TEL	0762344405
Homepage URL
Email	matusita@p.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanazawa University, Medical Institutional Review Board
Address	Takara-machi, 13-1, Kanazawa, Ishikawa
Tel	076-265-2103
Email	t-isomu@adm.kanazawa-u.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	2017 Year 01 Month 12 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	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2019 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029479