UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044456 |
|---|---|
| Receipt number | R000049508 |
| Scientific Title | Feasibility of Remote Intermitted-Scanned Glucose Monitoring in Hospitalized, Quarantined Covid-19 Patients |
| Date of disclosure of the study information | 2021/06/09 |
| Last modified on | 2022/12/09 12:06:38 |
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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
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
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049508
