UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of Remote Intermitted-Scanned Glucose Monitoring in Hospitalized, Quarantined Covid-19 Patients
Acronym	Feasibility of Remote Intermitted-Scanned Glucose Monitoring in Hospitalized, Quarantined Covid-19 Patients
Scientific Title	Feasibility of Remote Intermitted-Scanned Glucose Monitoring in Hospitalized, Quarantined Covid-19 Patients
Scientific Title:Acronym	Feasibility of Remote Intermitted-Scanned Glucose Monitoring in Hospitalized, Quarantined Covid-19 Patients
Region	Japan

Condition
Condition	COVID-19 hospitalized patients
Classification by specialty	Medicine in general Endocrinology and Metabolism Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the feasibility of remote intermitted-scanned glucose monitoring in hospitalized, quarantined covid-19 patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Profiles of sensor glucose level by intermitted-scanned continuous glucose monitoring
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	COVID-19 patients aged 20 years or older who were admitted to our hospital, (1) patients who have been diagnosed with diabetes before admission, and (2) patients who receive steroid treatment regardless of the presence or absence of diabetes.
Key exclusion criteria	1. Patients who did not agree to participate in this study 2. Patients scheduled to undergo surgery and MRI 3. Patients using implantable medical devices such as pacemakers 4. Patients with systemic edema 5. Patients with a hyperglycemic emergency (diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome) 6. Patients using acetaminophen of 4000mg or more per day 7. Patients who have difficulty wearing the continuous glucose monitoring sensor due to skin problems 8. Pregnant patients
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akinori Middle name Last name Hayashi
Organization	Kitasato University School of Medicine
Division name	Department of Laboratory Medicine
Zip code	252-0374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374 Japan
TEL	042-778-8111
Email	ahayashi@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Hayashi
Organization	Kitasato University School of Medicine
Division name	Department of Laboratory Medicine
Zip code	252-0374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374 Japan
TEL	042-778-8111
Homepage URL
Email	ahayashi@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	self funding
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	Research Ethics Committee of the Kitasato University School of Medicine
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374 Japan
Tel	0427788111
Email	rinrib@med.kitasato-u.ac.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	2021 Year 06 Month 09 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	20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 12 Month 22 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 06 Month 07 Day
Date of IRB	2021 Year 06 Month 07 Day
Anticipated trial start date	2021 Year 06 Month 07 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective and prospective observational study

Management information
Registered date	2021 Year 06 Month 07 Day
Last modified on	2022 Year 12 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049508