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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035148
Receipt No. R000040063
Official scientific title of the study Evaluation of plasma glucose change by Libre pro immediately after hospital discharge in type 2 diabetes with multiple daily insulin injection method
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

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Basic information
Official scientific title of the study Evaluation of plasma glucose change by Libre pro immediately after hospital discharge in type 2 diabetes with multiple daily insulin injection method
Title of the study (Brief title) DISCHARGE study
Region
Japan

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

Objectives
Narrative objectives1 We search for plasma glucose fluctuation, hypoglycemic frequency and appearance time after hospital discharge and establish safety requirements for insulin therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hypoglycemia (value, frequency, appearance time and duration)
Key secondary outcomes Changes in the amount of insulin, differences according to insulin type

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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients with HbA1c above 9.0 10%
(2) Patients introduced multiple daily insulin injection method during hospitalization
(3) Patients who is not in insulin dependence state
(4) Patients who has insulin requirement >= 15 units/day
(5) Patients whose plasma glucose daily fluctuation is stable
(6) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this trial
Key exclusion criteria (1) Type 1 diabetes mellitus patients
(2) Patients with severe liver disease
(3) Patients with severe renal disease
(4) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(5) Patients with severe pancreas disease
(6) Patients having a cancer
(7) Patients with hemoglobin (Hb) less than 11 g/dL
(8) Patients that the number of the platelets is less than 100,000 /mm3
(9) Patients with high diabetic neuropathy
(10) Patients having a proliferative retinopathy
(11) Patients with a serious infectious disease or a serious injury
(12) Patients with bowel disease or ileus factors
(13) Chronic enteropathy patients with the digestion and absorption abnormality
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant
(16) Patients who was infected with hepatitis B virus or hepatitis C virus
(17) In addition, the patient who judged inappropriate by an attendant physician
Target sample size 30

Research contact person
Name of lead principal investigator Masahiko Miyagi
Organization Toho University School of Medicine
Division name Division of diabetes, metabolism and endocrinology
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email miyagi-m@med.toho-u.ac.jp

Public contact
Name of contact person Masahiko Miyagi
Organization Toho University Omori Medical Center Hospital
Division name Diabetes, Metabolism and Endocrinology Center
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email miyagi-m@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization Toho University School of Medicine
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 12 Month 05 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 07 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 Use long-acting insulin as degludec or glargine U-300.

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040063

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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