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Recruitment status Completed
Unique ID issued by UMIN UMIN000011767
Receipt No. R000013759
Scientific Title Redefining Fundamental Learning of SMBG through Educational Color Tools study
Date of disclosure of the study information 2013/09/14
Last modified on 2013/09/14

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Basic information
Public title Redefining Fundamental Learning of SMBG through Educational Color Tools study
Acronym Redefining Fundamental Learning of SMBG through Educational Color Tools (REFLECT) Study
Scientific Title Redefining Fundamental Learning of SMBG through Educational Color Tools study
Scientific Title:Acronym Redefining Fundamental Learning of SMBG through Educational Color Tools (REFLECT) Study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate HbA1c and behavioral change of type 2 diabetic patients by using color educational tools.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c level(2,4, 6 months after intervention )
Key secondary outcomes 1)Change in consciousness by blood glucose results
2)Change in behavior by blood glucose results
3)Change in interest in blood glucose

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Control: using non-color SMBG device
Interventions/Control_2 Using a color-display SMBG device and color educational tools
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1)Subjects between 20 and 90 years old
2)HbA1c value is over 5.0% and under 13.0%
3)Subjects who can write a questionnaire and agree with it.
Key exclusion criteria 1)Subjects under 20 years old and over 90
2)Subjects with impaired vision
3)Subjects who have difficulty with comprehension and cannot use a SMBG device
4)Subjests who have serious desease
5)Subjects who have abnormal hemoglobin
6)Subjects who are not permitted to participate in this trial
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Suzuki
Organization SAISEIKAI NIIGATA DAINI HOSPITAL
Division name Metabolism and endocrinology
Zip code
Address 280-7, Teraji, Niigata-shi, Niigata-ken
TEL 025-233-6161
Email katsu-s@ngt.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsunori Suzuki
Organization SAISEIKAI NIIGATA DAINI HOSPITAL
Division name Metabolism and endocrinology
Zip code
Address 280-7, Teraji, Niigata-shi, Niigata-ken
TEL 025-233-6161
Homepage URL
Email katsu-s@ngt.saiseikai.or.jp

Sponsor
Institute SAISEIKAI NIIGATA DAINI HOSPITAL
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Address
Tel
Email

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
2013 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 14 Day
Last modified on
2013 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013759


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