UMIN-CTR Clinical Trial

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
Email	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
Email	yukihiro_hasegawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center Clinical Research Support Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048048