UMIN-CTR Clinical Trial

Basic information
Public title	The study about changes of the Summary of Diabetes Self-Care Activities (SDSCA) measure in patients who use Free Style Libre.
Acronym	Changes of SDSCA in patients with Free Style Libre.
Scientific Title	The study about changes of the Summary of Diabetes Self-Care Activities (SDSCA) measure in patients who use Free Style Libre.
Scientific Title:Acronym	Changes of SDSCA in patients with Free Style Libre.
Region	Japan

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

Objectives
Narrative objectives1	To study about changes of the Summary of Diabetes Self-Care Activities (SDSCA) measure in patients who use Free Style Libre.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	SDSCA score (diet, exercise, blood sugar testing, medication).
Key secondary outcomes	HbA1c, gulicoalbumin, bodyweight.

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Patients are equipped with Free Style Libre more than two weeks per month for 6 months. Diet and exercise instruction from a dietitian and a nurse or a clinical laboratory technician for 30 minutes at the start. The Summary of Diabetes Self-Care Activities (SDSCA) measure at the 0, 4th, 12th, 24th week. Questionnaire about Free Style Libre at the 12th week. In both groups, at the start of study and for every 4 week, we measure body weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbmin. At the start of study and for every 12 week, we measure serum AST, ALT, gamma-GTP, BUN, creatinine, UA, eGFR, urine albumin creatinine ratio (mg/gCr), LDL-C, HDL-C, TG.
Interventions/Control_2	Patients monitor their blood glucose level with only conventional blood glucose meters for 6 months. Diet and exercise instruction from a dietitian and a nurse or a clinical laboratory technician for 30 minutes at the start. The Summary of Diabetes Self-Care Activities (SDSCA) measure at the 0, 4th, 12th, 24th week.
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	15 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Out-patients with diabetes who daily monitor their blood glucose level by themselves with conventional blood glucose meter.
Key exclusion criteria	Patients judged by the doctor to be ineligible
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Tosaki
Organization	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name	Diabetes and Endocrinology
Zip code	4680009
Address	2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL	052-800-2333
Email	nrd49075@nifty.com

Public contact
Name of contact person	1st name Takahiro Middle name Last name Tosaki
Organization	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name	Diabetes and Endocrinology
Zip code	4680009
Address	Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL	052-800-2333
Homepage URL
Email	nrd49075@nifty.com

Sponsor
Institute	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department

Funding Source
Organization	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
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	Ethic commitee of TDE Healthcare Corporation
Address	2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
Tel	0528002333
Email	nrd49075@nifty.com

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	医療法人TDE　糖尿病・内分泌内科クリニックTOSAKI

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://diabetes.diabetesjournals.org/content/67/Supplement_1/902-P
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	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 05 Day
Last follow-up date	2018 Year 09 Month 04 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 09 Month 05 Day
Last modified on	2020 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033160