UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012307
Receipt number R000014369
Scientific Title Continuous blood glucose monitoring by artificial pancreas in patients with intracranial hypertension
Date of disclosure of the study information 2013/11/18
Last modified on 2017/02/10 18:44:59

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Continuous blood glucose monitoring by artificial pancreas in patients with intracranial hypertension

Acronym

Blood Glucose Monitoring by Artificial Pancreas -Intracranial Hypertension (GMAP-IH)

Scientific Title

Continuous blood glucose monitoring by artificial pancreas in patients with intracranial hypertension

Scientific Title:Acronym

Blood Glucose Monitoring by Artificial Pancreas -Intracranial Hypertension (GMAP-IH)

Region

Japan


Condition

Condition

Patients having brain diseases (brain trauma, stroke, and brain tumor, etc.) suffers intracranial hypertension which requires emergency decompressive surgery.

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study evaluates that continuous blood glucose monitoring predicts effects of decompression in emergency operations in patients with intracranial hypertension.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between glucose change and decompressive manuplation during surgery

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

During decompressive surgery blood glucose is continuously monitored by artificial pancreas. Blood is sampled at a 2mL/hr from peripheral vein.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Unconscious (JCS 10-200)
Tolerable for general anesthesia
Men and women of 20 years of age or older
Unnecessary of insulin treatment
Informed consent written by legally acceptable representative

Key exclusion criteria

Necessary of insulin treatment
Requirement of glucose administration before and during surgery
Pregnant or lactating women and women of child bearing potential
Patients judged by investigators ineligible for participation as study subjects for any other reason.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

Neurosurgery

Zip code


Address

2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan

TEL

072-683-1221

Email

neu070@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motomasa Furuse

Organization

Osaka Medical College

Division name

Neurosurgery

Zip code


Address

2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan

TEL

072-683-1221

Homepage URL


Email

neu054@poh.osaka-med.ac.jp


Sponsor or person

Institute

Department of Neurosurgery, Osaka Medical college

Institute

Department

Personal name



Funding Source

Organization

ZENKYOREN (Natinal Mutual Insurance Federation of Agricultural Cooperatives)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Department of Neurosurgery, Osaka Medical College


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

大阪医科大学附属病院(大阪府)
(Osaka Medical College Hospital)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 18 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

2013 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 27 Day

Last follow-up date

2016 Year 10 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 05 Month 31 Day

Date analysis concluded

2017 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 15 Day

Last modified on

2017 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name