UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036964
Receipt number R000042114
Scientific Title Risk of hyperglycemia and hypoglycemia in patients with acute ischemic stroke based on continuous glucose monitoring
Date of disclosure of the study information 2019/06/04
Last modified on 2019/12/20 11:37:55

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Basic information

Public title

Blood glucose variability in acute ischemic stroke patients

Acronym

Blood glucose variability in acute ischemic stroke patients

Scientific Title

Risk of hyperglycemia and hypoglycemia in patients with acute ischemic stroke based on continuous glucose monitoring

Scientific Title:Acronym

Continuous glucose monitoring in acute stroke patients

Region

Japan


Condition

Condition

acute ischemic stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aimed to assess glucose variability by
continuous glucose monitoring (CGM) and to demonstrate the risk of acute ischemic
stroke patients with glucose levels outside of the glucose management
recommendations.

Basic objectives2

Others

Basic objectives -Others

The aim of the present study was to demonstrate the risk profile of acute ischemic stroke patients who will develop abnormal CGM glucose levels (<60 mg/dl and >180 mg/dl) in order to establish suitable blood glucose monitoring in the management of acute ischemic stroke patients.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Frequencies of hypoglycemia and hyperglycemia during the 72-hour monitoring period

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The Free Style Libre Pro (Abbott Japan Inc., Tokyo, Japan), was applied on the back of the upper arm.

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

Acute ischemic stroke patients admitted within seven days after onset were
prospectively enrolled.

Key exclusion criteria

Excluded were patients with pregnancy, hemodialysis, another implanted device such as a pacemaker, serious illness, and upper arm skin disorder.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name HISANAO
Middle name
Last name AKIYAMA

Organization

St. Marianna University School of Medicine

Division name

Department of Neurology

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

+81449778111

Email

h2akiyama@marianna-u.ac.jp


Public contact

Name of contact person

1st name HISANAO
Middle name
Last name AKIYAMA

Organization

St Marianna University School of Medicine

Division name

Department of Neurology

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

+81449778111

Homepage URL


Email

h2akiyama@marianna-u.ac.jp


Sponsor or person

Institute

Department of Neurology, St Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Neurology, St Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JPN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St Marianna University School of Medicine

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

Tel

+81449778111

Email

h2akiyama@marianna-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

2019 Year 06 Month 04 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S1052305719303994?via%3Dihub

Number of participants that the trial has enrolled

39

Results

CGM showed hypoglycemic events in 19 patients and hyperglycemic events in 21 patients, and the frequencies of hypo- and hyperglycemic events during CGM were 10.1% and 11.9%, respectively. Hypoglycemic events were mainly observed in the night-time in patients with normoglycemia at admission. Logistic regression analyses demonstrated significant associations between the blood glucose level at admission and hypo- and hyperglycemic events on CGM.

Results date posted

2019 Year 12 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 09 Month 21 Day

Baseline Characteristics

Patients with ischemic stroke admitted within 7 days after onset were prospectively enrolled, and their blood glucose levels were monitored every 15 minutes for 72-hour period using the FreeStyle Libre Pro. Multivariate logistic regression analyses were used to analyze potential predictors for hyperglycemic (>180 mg/dL) and hypoglycemic (<60 mg/dL) events.

Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 10 Month 22 Day

Date of IRB

2018 Year 10 Month 22 Day

Anticipated trial start date

2018 Year 10 Month 22 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 04 Day

Last modified on

2019 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042114


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name