UMIN-CTR Clinical Trial

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

Infectious Disease Patients with Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

05

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

05

Month

17

Day

Last modified on

2015

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020400