UMIN-CTR Clinical Trial

Basic information
Public title	Appropriate Dosage of Long-acting Insulin at the Time of Artificial Pancreas Withdrawal
Acronym	Appropriate Dosage of Long-acting Insulin at the Time of Artificial Pancreas Withdrawal
Scientific Title	Optimal dose of long-acting insulin analogue for withdrawal of artificial pancreas after hepatectomy -pilot study-
Scientific Title:Acronym	Optimal dose of long-acting insulin analogue for withdrawal of artificial pancreas after hepatectomy -pilot study-
Region	Japan

Condition
Condition	liver cancer, Diabetes
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find an appropriate formula to determine the amount of long-acting insulin at the time of artificial pancreas withdrawal.
Basic objectives2	Others
Basic objectives -Others	Appropriate long-acting insulin dose at the time of artificial pancreas withdrawal
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Approximate formula for determining basal insulin dose at the time of artificial pancreas withdrawal
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	55 years-old <=
Age-upper limit	82 years-old >=
Gender	Male and Female
Key inclusion criteria	A case of partial/ lobectomy of the liver with bedside type artificial pancreas STG-55 (Nikkiso)
Key exclusion criteria	Cases of withdrawal from artificial pancreas
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Atsuhito Middle name Last name Tone
Organization	Okayama Saiseikai General Hospital
Division name	Department of Internal Medicine, Diabetes Center
Zip code	700-8511
Address	2-25 Kokutai-cho, Kita-ku, Okayama City
TEL	086-252-2211
Email	aitone@ms1.megaegg.ne.jp

Public contact
Name of contact person	1st name Toshihisa Middle name Last name Tahara
Organization	Okayama Saiseikai General Hospital
Division name	Department of Internal Medicine, Diabetes Center
Zip code	700-8511
Address	2-25 Kokutai-cho, Kita-ku, Okayama City
TEL	086-252-2211
Homepage URL
Email	tt.toshihisa.tahara@gmail.com

Sponsor
Institute	Okayama Saiseikai General Hospital
Institute
Department

Funding Source
Organization	Okayama Saiseikai General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama Saiseikai General Hospital
Address	2-25 Kokutai-cho, Kita-ku, Okayama City
Tel	086-252-2211
Email	tt.toshihisa.tahara@gmail.com

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	2022 Year 08 Month 30 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	27
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	2021 Year 05 Month 01 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Patients who underwent partial/ lobectomy of the liver between October 1, 2019 and May 31, 2021. measurement item The 24-hour insulin amount calculated from the insulin infusion rate at the time of withdrawal from the artificial pancreas, and the 24-hour insulin amount calculated from the insulin amount used in the artificial pancreas from the operation to the next morning , preoperative basal insulin level, fasting CPR, HbA1c, body weight, and lactic acid level

Management information
Registered date	2022 Year 08 Month 29 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053918