UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Acronym	The glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Scientific Title	Comparison of the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Scientific Title:Acronym	The glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Region	Japan

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

Objectives
Narrative objectives1	To compare the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The formulae which predict the following glycemic variability metrics values calculated using CGM sensor glucose (every 5 minutes [iPro2]) from those calculated using FGM sensor glucose (every 15 minutes [FreeStyle Libre Pro]). (if significant association exists) Percentage of time in target range (70~180 mg/dL) Mean absolute glucose (MAG) Glycemic variability percentage (GVP) Mean glucose level Standard deviation (SD) Coefficient of variation (CV) Low blood glucose index (LBGI) High blood glucose index (LBGI)
Key secondary outcomes	The association between glycemic variability metrics values (every 5 minutes [iPro2], 15 (extraction) minutes [iPro2], and 15 minutes [FreeStyle Libre Pro]) (except primary endpoint)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	120 patients with type 2 diabetes wear continuous glucose monitor devices (iPro2 and FreeStyle Libre Pro) and 24-h glucose levels were simultaneously measured continiuously. iPro2 is worn on 6 days after FreeStyle Libre Pro is worn. We analyse the continuous glucose monitor data from 00:00 to 24:00 (iPro2: on day 2 and FreeStyle Libre Pro: on day 8 (Same period)).
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 who agree wearing CGMs (iPro2 and FreeStyle Libre Pro) simultaneously
Key exclusion criteria	Judged to be unsuitable for participation for medical reasons
Target sample size	120

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	2018 Year 07 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	2018 Year 07 Month 16 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 07 Month 26 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

Management information
Registered date	2018 Year 07 Month 18 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038121