UMIN-CTR Clinical Trial

Basic information
Public title	Prediction for glycemic variability in patients treated with insulin glargine 300 U/ml on basal insulin therapy
Acronym	Prediction for glycemic variability in insulin glargine 300 U/ml
Scientific Title	Prediction for glycemic variability in patients treated with insulin glargine 300 U/ml on basal insulin therapy
Scientific Title:Acronym	Prediction for glycemic variability in insulin glargine 300 U/ml
Region	Japan

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

Objectives
Narrative objectives1	To investigate how to predict glycemic variability or hypoglycemia in patients treated with insulin glargine 300 U/ml on basal insulin therapy from a few measurement
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A time and a cutoff value which can the most exactly predict TIR(70 to 180 mg/dL) < 70 percent
Key secondary outcomes	Times which the most correlate to CV or TBR(< 70 mg/dL) Times and cutoff values which can the most exactly predict CV > 36 percent or TBR(< 70 mg/dL)< 4 percent Times during daytime where differences between two glucose levels the most correlate to CV or TBR(< 70 mg/dL) Times during daytime where differences between two glucose levels can the most exactly predict CV > 36 percent or TBR(< 70 mg/dL)< 4 percent and those cutoff values

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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with type 2 diabetes treated with insulin glargine 300 U/ml on basal insulin therapy during hospitalization
Key exclusion criteria	judged to be unsuitable for participation for medical reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Soichi Middle name Last name Takeishi
Organization	Inuyama Chuo General Hospital
Division name	Diabetes
Zip code	484-8511
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Email	souichi19811225@yahoo.co.jp

Public contact
Name of contact person	1st name Soichi Middle name Last name Takeishi
Organization	Inuyama Chuo General Hospital
Division name	Diabetes
Zip code	484-8511
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization	Inuyama Chuo General 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	Inuyama Chuo General Hospital
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
Tel	0568-62-8111
Email	souichi19811225@yahoo.co.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	2020 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	54
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 10 Month 01 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 02 Month 08 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We cross-sectionally analyzed 24-h glucose levels for patients with type 2 diabetes treated with insulin glargine 300 U/ml on basal insulin therapy during hospitalization using continuous glucose monitor (CGM) (iPro2).

Management information
Registered date	2020 Year 02 Month 08 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044960