UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of calibration accuracy between point-of-care devices and glucometers when using personal CGM
Acronym	Comparison of calibration accuracy between point-of-care devices and glucometers
Scientific Title	Comparison of calibration accuracy between point-of-care devices and glucometers when using personal CGM
Scientific Title:Acronym	Comparison of calibration accuracy between point-of-care devices and glucometers
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 calibration accuracy between point-of-care devices (POCT) and glucometers that were compliant with ISO15197:2013 (ISO) when using personal CGM
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MARD for POCT and SMBG when using venous blood glucose levels (n = 48)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Study participants are 24 patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. We evaluate pre-prandial and bedtime glucose levels on days 2 to 5 of wearing the CGM devices, in addition, we also evaluate postprandial glucose levels on days 2 and 5. POCTSMBG group: days 2 and 3: POCT, days 4 and 5: ISO. Calibration is performed using venous blood glucose levels at pre- and post-breakfast on days 2-5, and that is performed using capillary blood glucose levels at the others.
Interventions/Control_2	Study participants are 24 patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. We evaluate pre-prandial and bedtime glucose levels on days 2 to 5 of wearing the CGM devices, in addition, we also evaluate postprandial glucose levels on days 2 and 5. SMBGPOCT group: days 2 and 3: ISO, days 4 and 5: POCT. Calibration is performed using venous blood glucose levels at pre- and post-breakfast on days 2-5, and that is performed using capillary blood glucose levels at the others.
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 wear personal and professional CGM in parallel for 6 days.
Key exclusion criteria	judged to be unsuitable for participation for medical reasons
Target sample size	24

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	0568628111
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 12 Month 06 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	16
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	2020 Year 08 Month 15 Day
Date of IRB	2020 Year 12 Month 04 Day
Anticipated trial start date	2020 Year 12 Month 06 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 06 Day
Last modified on	2021 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048682