UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020729 |
|---|---|
| Receipt number | R000023917 |
| Scientific Title | Hypoglycemia and glycemic variability are associated with survival rate after admission in hospitalized terminal cancer patients with diabetes mellitus(retrospective study) |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2016/03/03 18:12:11 |
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Basic information
Public title
Hypoglycemia and glycemic variability are associated with survival rate after admission in hospitalized terminal cancer patients with diabetes mellitus(retrospective study)
Acronym
Hypoglycemia and glycemic variability are associated with survival rate after admission in terminal cancer patients with diabetes mellitus
Scientific Title
Hypoglycemia and glycemic variability are associated with survival rate after admission in hospitalized terminal cancer patients with diabetes mellitus(retrospective study)
Scientific Title:Acronym
Hypoglycemia and glycemic variability are associated with survival rate after admission in terminal cancer patients with diabetes mellitus
Region
| Japan |
Condition
Condition
diabetes mellitus
cancer
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the relationship of survival rate after admission with prognostic factors of cancer and glycemic variability in hospitalized terminal cancer patients with diabetes mellitus who underwent interventions for glycemic control.
Basic objectives2
Others
Basic objectives -Others
epidemiology of diabetic complication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We extracted data regarding prognostic factors of cancer on day 1 of hospital stay, change in prognostic factors of cancer, glycemic variability (GV; coefficient of variation [CV] and standard deviation [SD]), and mean glucose concentrations during the entire hospital stay. We analyzed the association of mortality and survival rate with these factors.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We retrospectively analyzed 504 hospitalized terminal cancer patients with diabetes mellitus who underwent glucose monitoring >3 times per day during a 6-year period from 2009 to 2015. We evaluated survival rate after admission within 90 days after admission.
Key exclusion criteria
Patients with long durations of hospital stay (>90 days) and those who underwent very few sessions of glucose monitoring (<6 times in total) were excluded.
Target sample size
504
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
0586-48-0077
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
0586-48-0077
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
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
| 2016 | Year | 01 | Month | 25 | 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
| 2015 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively analyzed the cases of 704 diabetic patients admitted in hospital for various cancers (non-ICU) who underwent glucose monitoring >3 times per day.
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023917
