UMIN-CTR Clinical Trial

Basic information
Public title	A pilot clinical trial of introduction and adjustment algorithm of insulin degludec in hospitalized patients with type 2 diabetes.
Acronym	I-deg trial
Scientific Title	A pilot clinical trial of introduction and adjustment algorithm of insulin degludec in hospitalized patients with type 2 diabetes.
Scientific Title:Acronym	I-deg trial
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In hospitalized patients with poor glycemic control, treatment is generally initiated with insulin to reverse glucose toxicity, but there is no established method for dose adjustment. We examined the efficacy and safety of an adjustment method of insulin degludec in hospitalized patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of days required to achieve a fasting blood glucose level of 130 mg/dl or less, hospitalization, hypoglycemia
Key secondary outcomes

Base
Study type	Observational

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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	hospitalized type2 diabetes patients at 2017/9-2018/3
Key exclusion criteria	a) The patient who became the hospitalization for an unexpected reason except the insulin adjustment. The patient who other diseases including the b) malignant tumor were found out, and came to cannot but extend length of stay c) Type I diabetes mellitus patient d) The patient whom a factor to affect the blood sugar level including the steroid medicine clearly produced e) The patient who does not adjust it using algorithm
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shuhei Middle name Last name Nishina
Organization	Kansai Rosai Hospital
Division name	Department of Diabetes and Endocrinology
Zip code	650-8511
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Email	shuhee247@yahoo.co.jp

Public contact
Name of contact person	1st name Shuhei Middle name Last name Nishina
Organization	Kansai Rosai Hospital
Division name	Department of Diabetes and Endocrinology
Zip code	650-8511
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Homepage URL
Email	shuhee247@yahoo.co.jp

Sponsor
Institute	Department of Diabetes and Endocrinology, Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Kansai Rosai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kansai Rosai Hospital
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
Tel	06-6416-1221
Email	postmaster@kansaih.johas.go.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 08 Month 09 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	31
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	2019 Year 03 Month 04 Day
Date of IRB	2019 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 19 Day
Last follow-up date	2019 Year 03 Month 19 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information	Retrospective cohort study

Management information
Registered date	2019 Year 08 Month 09 Day
Last modified on	2019 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042920