UMIN-CTR Clinical Trial

Basic information
Public title	Examination of SMBG patient education guidance based on Time in Range
Acronym	Examination of SMBG patient education guidance based on Time in Range
Scientific Title	Examination of SMBG patient education guidance based on Time in Range
Scientific Title:Acronym	Examination of SMBG patient education guidance based on Time in Range
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Conventionally, HbA1c is generally used as an index for blood glucose control. However, it is known that cases in which fasting hypoglycemia is frequent or cases in which postprandial hyperglycemia is observed even in the normal fasting blood glucose range are likely to cause macrovascular disorders despite the fact that the HbA1c level is a good control. 1) 2) In other words, in order to prevent complications of diabetes, evaluation with HbA1c is insufficient, and it is necessary to grasp blood glucose levels before and after meals. As a new glycemic control index, blood glucose 70-180 mg / dL is defined as the therapeutic range, and the number of measurements or time in this range is defined as Time in Range (TIR). In this study, we aim to examine whether the goal of measurement by autoglycemia measurement (SMBG) is 7 points per day (90 minutes before meals, 90 minutes after meals, and before sleep: see DCCT study) and whether the progression of complications is prevented and whether the behavior change and treatment motivation of control patients have improved by using a measurement sheet (SMBG coach) aiming at the range of TIR for patient guidance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Patient Satisfaction Survey 2.HbA1c Levels at Week 16 After Initiation of SMBG Coach Coaching Intervention
Key secondary outcomes	1.Correlation between SMBG's TIR and HbA1c 2.Changes in body weight (BMI), changes in muscle mass and fat mass due to inbody measurement, Blood pressure, biochemical examination

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Self Monitoring of blood glucose.Blood glucose measurement 7 times a day.
Interventions/Control_2	Medical treatment guidance.At the time of research entry, at week 8 and week 16,Conduct questionnaire surveys and diet and exercise therapy, etc.
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. Patients who, after receiving a sufficient explanation, obtained written consent of their own free will after receiving sufficient explanations for participation in this study. 2. Patients who are 20 years of age or older at the time of obtaining consent 3. Type 2 diabetic patients who introduce SMBG through insulin treatment 4. Patients with SMBG measurement 5. Patients with exercise therapy 6. Patients with an HbA1c value of 7.0% or more but less than 10%
Key exclusion criteria	1. Patients with an HbA1c value of less than 7.0% or more than 10% 2. Patients with neuropsychiatric disorders such as depression or alcoholism that appear to affect the evaluation of the trial 3. Patients with a malignant neoplasm 4. Patients with nephropathy stage 4 or more 5. Patients with restricted movement 6,Patients undergoing steroid therapy, anticancer drugs, interferon, or other treatments that affect blood sugar levels 7.Patients whose lead investigator or co-investigator determines that participation in the study is inappropriate from the viewpoint of the content of the study and safety.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Suzuki
Organization	Fujita Health University School of Medicine
Division name	Department of Endocrinology,Diabetes and Metabolism
Zip code	470-1192
Address	1-98,Dengakugakubo,Kutsukake,Toyoake,Aichi
TEL	0562-93-9242
Email	aslapin@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Seino
Organization	Fujita Health University School of Medicine
Division name	Department of Endocrinology,Diabetes and Metabolism
Zip code	470-1192
Address	1-98,Dengakugakubo,Kutsukake,Toyoake,Aichi
TEL	0562-93-9242
Homepage URL
Email	seinoy@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine Department of Endocrinology,Diabetes and Metabolism
Institute
Department

Funding Source
Organization	Fujita Health University School of Medicine Department of Endocrinology,Diabetes and Metabolism
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fujita Health University School of Medicine Department of Endocrinology,Diabetes and Metabolism
Address	1-98,Dengakugakubo,Kutsukake,Toyoake,Aichi
Tel	0562-93-9242
Email	chopin12@fujita-hu.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	2022 Year 07 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2024 Year 12 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	2022 Year 06 Month 30 Day
Last modified on	2022 Year 06 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054680