UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of the new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Title of the study (Brief title)	The new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Region	Japan

Condition
Condition	Patients with diabetes mellitus who are going to be undergone digestive surgery
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the optimal concentration of perioperative glycemic control effective to prevent postoperative infectious complications in patients with diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgical site infection (SSI)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Group A (Targeted blood glucose range is from 80 to 110 mg/dl)
Interventions/Control_2	Group B (Targeted blood glucose range is from 110 to 140 mg/dl)
Interventions/Control_3	Group C (Targeted blood glucose range is from 140 to 180 mg/dl)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with diabetes mellitus who are going to be undergone digestive surgery
Key exclusion criteria	none
Target sample size	150

Research contact person
Name of lead principal investigator	Kazuhiro Hanazaki
Organization	Kochi Medical School
Division name	Department of Surgery 1
Address	Kohasu, Okocho, Nankoku, Kochi
TEL	088-880-2370
Email	im-31@kochi-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kitagawa
Organization	Kochi Medical School
Division name	Department of Surgery 1
Address	Kohasu, Okocho, Nankoku, Kochi
TEL	088-880-2370
Homepage URL
Email	kitagawah@kochi-u.ac.jp

Sponsor
Institute	Department of Surgery 1, Kochi Medical School
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 02 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 12 Month 07 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 10 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008104