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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033275
Receipt No. R000037566
Official scientific title of the study Efficacy of the Flash Glucose Monitoring System in diabetic patients
Date of disclosure of the study information 2018/07/05
Last modified on 2018/07/04

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Basic information
Official scientific title of the study Efficacy of the Flash Glucose Monitoring System in diabetic patients
Title of the study (Brief title) Efficacy of the Flash Glucose Monitoring System in diabetic patients
Region
Japan

Condition
Condition Diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of the flash glucose monitoring system in diabetic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c

Key secondary outcomes patient reported outcome
questionnaire survey
glucose variability
blood pressure
body weight
metabolic parameter

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Out patients who receive therapy at our hospital

Patients who give written informed consent to participate in the study
Key exclusion criteria Hypersensitivity to medical patches
Target sample size 100

Research contact person
Name of lead principal investigator Satoshi Ida
Organization Ise Red Cross Hospital
Division name Department of diabetes and metabolism
Address 1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL 0596-28-2171
Email bboy98762006@yahoo.co.jp

Public contact
Name of contact person Satoshi Ida
Organization Ise Red Cross Hospital
Division name Department of diabetes and metabolism
Address 1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL 0596-28-2171
Homepage URL
Email bboy98762006@yahoo.co.jp

Sponsor
Institute Ise Red Cross Hospital
Department of diabetes and metabolism
Institute
Department

Funding Source
Organization Ise Red Cross Hospital
Department of diabetes and metabolism
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2018 Year 07 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We analyse the flash glucose monitoring system data.

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037566

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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