UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042103 |
|---|---|
| Receipt number | R000048048 |
| Scientific Title | A multi-institutional, prospective study on continuous subcutaneous glucose monitoring in healthy children |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/13 17:56:39 |
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Basic information
Public title
Continuous glucose monitoring study in healthy children
Acronym
CGM-study
Scientific Title
A multi-institutional, prospective study on continuous
subcutaneous glucose monitoring in healthy children
Scientific Title:Acronym
Continuous subcutaneous glucose monitoring study
in healthy children: CGM-HC study
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Endocrinology and Metabolism | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify a normal range of continuous subcutaneous glucose levels in healthy children
Basic objectives2
Others
Basic objectives -Others
Comparison with a range of continuous subcutaneous glucose levels in type 1A Diabetic children
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of CGM data less than 70 mg/dL
Key secondary outcomes
Timing of CGH data less than 70 mg/dL
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
CGM device
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
| 4 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Medical staff or siblings of type 1 diabetes patients
at the two research facilities
2) Normal BMI within 10-90 th percent
3) Normal Hb A1c levels
4) No past history of medicine which may influence
glucose metabolism for the previous seven days
5) Informed consent/ascent after the explanation given
Key exclusion criteria
No consent is available.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
183-8561
Address
2-8-29 Musashi-dai, Futyu, Tokyo, Japan
TEL
81-424-300-5111
yukihiro_hasegawa@tmhp.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
183-8561
Address
2-8-29 Musashi-dai, Futyu, Tokyo, Japan
TEL
81-424-300-5111
Homepage URL
https://www.byouin.metro.tokyo.lg.jp/shouni/section/rinshoukenkyu_index.html
yukihiro_hasegawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Clinical Research Support Center
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Hokkaido University,
School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center, Division of Endocrinology and Metabolism
Address
Tokyo Metropolitan Children's Medical Center, Division of Endocrinology and Metabolism
Tel
042-300-5111/81-42-300-5111
yukihiro_hasegawa@tmhp.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
東京都立小児総合医療センター Tokyo Metropolitan Children’s Medical Center, 北海道大学医学部小児科 Hokkaido University, School of Medicine, Department of Pediatrics
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048048
