UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035148 |
|---|---|
| Receipt number | R000040063 |
| Scientific Title | Evaluation of plasma glucose change by Libre Pro shortly 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 | 2021/06/08 12:44:22 |
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Basic information
Public title
Evaluation of plasma glucose change by Libre Pro shortly after hospital discharge in type 2 diabetes with multiple daily insulin injection method
Acronym
Doses of Insulin Should be CHanged According to Reported GlucosE by Libre Pro (DISCHARGe) study
Scientific Title
Evaluation of plasma glucose change by Libre Pro shortly after hospital discharge in type 2 diabetes with multiple daily insulin injection method
Scientific Title:Acronym
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 research for plasma glucose fluctuation, hypoglycemic frequency and appearance time after hospital discharge, and hope to 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, Difference due to insulin preparation
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%
(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
| 1st name | Manabu |
| Middle name | |
| Last name | Saito |
Organization
Toho University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Manabu.saitou@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Miyagi |
Organization
Toho University Omori Medical Center Hospital
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
miyagi-m@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
The Ethics Committee of the Toho University Omori Medical Center Hospital
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
Tel
03-3762-4151
somuomori@jim.toho-u.ac.jp
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 |
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As long-acting insulin, we use insulin degludec or glargine U-300.
Management information
Registered date
| 2018 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040063
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
