UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048202 |
|---|---|
| Receipt number | R000054680 |
| Scientific Title | Examination of SMBG patient education guidance based on Time in Range |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/30 12:49:49 |
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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
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
seinoy@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Department of Endocrinology,Diabetes and Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054680
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