UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029454
Receipt No. R000033380
Scientific Title Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Date of disclosure of the study information 2017/10/07
Last modified on 2019/01/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Acronym Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Scientific Title Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Scientific Title:Acronym Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Region
Japan

Condition
Condition Type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective is to investigate the good level of HbA1c and combination of oral hypoglycemic agent, without including hypoclycemia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of hypoglycemia
time of hypoglycemia
(hypoglycemia:below 70mg/dl)
Key secondary outcomes frequency of hyperglycemia
time of hyperglycemia
(hyperglycemia:180mg/dl or more)

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria outpatient
type2 diabetes mellitus
65 years old and more
HbA1c level is below 8% on recent 3 months
Patients taking oral hypoglycemic agent, continuing it for 6 months and more, not changing it recent 3 months
Patients consented to participate in this study
Key exclusion criteria using insulin
using GLP1 analogue
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Odawara
Organization Tokyo Medical University
Division name Diabetology, Metabolism, and Endocrinology
Zip code
Address 6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL +81-3-3342-6111
Email odawara@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junpei Shikuma
Organization Tokyo Medical University
Division name Diabetology, Metabolism, and Endocrinology
Zip code
Address 6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL +81-3-3342-6111
Homepage URL
Email inugumitoui@yahoo.co.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
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
2017 Year 10 Month 07 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 Completed
Date of protocol fixation
2017 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 25 Day
Last follow-up date
2019 Year 01 Month 16 Day
Date of closure to data entry
2019 Year 01 Month 16 Day
Date trial data considered complete
2019 Year 01 Month 16 Day
Date analysis concluded
2019 Year 01 Month 16 Day

Other
Other related information observational study

Management information
Registered date
2017 Year 10 Month 06 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.