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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017598
Receipt No. R000020400
Scientific Title Hypoglycemia and Glycemic Variability are Associated with Mortality in Non-Intensive Care Unit Hospitalized Infectious Disease Patients with Diabetes Mellitus (retrospective study)
Date of disclosure of the study information 2015/05/17
Last modified on 2015/05/17

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Basic information
Public title Hypoglycemia and Glycemic Variability are Associated with Mortality in Non-Intensive Care Unit Hospitalized Infectious Disease Patients with Diabetes Mellitus
(retrospective study)
Acronym Hypoglycemia, GV, and mortality in diabetes.
Scientific Title Hypoglycemia and Glycemic Variability are Associated with Mortality in Non-Intensive Care Unit Hospitalized Infectious Disease Patients with Diabetes Mellitus
(retrospective study)
Scientific Title:Acronym Hypoglycemia, GV, and mortality in diabetes.
Region
Japan

Condition
Condition Infectious Disease Patients with Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 it is not well understood which factors -glycemic control, reactive inflammatory biomarkers, or vital signs are most associated with mortality in non-ICU hospitalized infectious disease patients with diabetes mellitus.
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We extracted age, sex, body mass index (BMI), glycosylated hemoglobin (HbA1c), reactive inflammatory biomarkers (i.e. white blood cell (WBC) and CRP), and vital signs data (i.e. body temperature (BT), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and SpO2) on the first day of hospital stay. Hypoglycemia, GV (standard deviation (SD) (18, 19), coefficient of variation (CV) (20, 21)) and mean glucose concentrations were determined from all glycemic data during the entire hospital stay. We analyzed the association between these factors (explanatory variable) and mortality (response variable) using univariate logistic regression analysis. And we analyzed the association between the factors which were significantly associated with mortality using univariate logistic regression analysis (explanatory variable) and mortality (response variable) using stepwise multivariate logistic regression analysis.
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
100 years-old >
Gender Male and Female
Key inclusion criteria We retrospectively analyzed 631 non-ICU infectious disease patients with diabetes mellitus who underwent glucose monitoring more than twice per day.
Key exclusion criteria The exclusion criteria for the study included: patient admissions with very long hospital stays (> 180 days) and patient admissions with very few glucose monitoring measurements (< total 6 times).
Target sample size 631

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
Email 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
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital
Institute
Department

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
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
2015 Year 05 Month 17 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
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 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 631 non-ICU infectious disease patients with diabetes mellitus who underwent glucose monitoring more than twice per day. We extracted reactive inflammatory biomarkers and vital signs data for the first day of hospital stay, and determined hypoglycemia, glycemic variability (GV) (i.e. coefficient of variation (CV) and standard deviation (SD)), and mean glucose concentrations from all glycemic data during the entire hospital stay. We analyzed the association between these factors and patient mortality using univariate and stepwise multivariate logistic regression analysis.

Management information
Registered date
2015 Year 05 Month 17 Day
Last modified on
2015 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020400

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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