UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029016 |
|---|---|
| Receipt number | R000033160 |
| Scientific Title | The study about changes of the Summary of Diabetes Self-Care Activities (SDSCA) measure in patients who use Free Style Libre. |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2020/03/22 21:04:57 |
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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
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
nrd49075@nifty.com
Sponsor or person
Institute
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033160
