UMIN-CTR Clinical Trial

Basic information
Public title	Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Acronym	HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Scientific Title	Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Scientific Title:Acronym	HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Region	Japan

Condition
Condition	Diabetic hemodialysis patients
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively analyze the glycemic profiles on both hemodialysis day / non-hemodialysis day in diabetic hemodialysis patients by continuous glucose monitoring (CGM) and reveal of the hemodialysis-induced hypoglycemia and glycemic disarrays often, factors that contribute to them.
Basic objectives2	Others
Basic objectives -Others	Glycemic profiles by CGM, HbA1c and glycated albumin.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The frequency of hemodialysis-induced hypoglycemia and glycemic disarray and its factors.
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	Diabetic hemodialysis patients who previously attached CGM in Kitasato University Hospital and Soubudai Nieren Clinic
Key exclusion criteria	(1) Patients with insufficient CGM data (2) Patients with insufficient blood test results (3) Patients who refused to participant this study
Target sample size	138

Research contact person
Name of lead principal investigator	1st name Akinori Middle name Last name Hayashi
Organization	Kitasato University School of Medicine
Division name	Endocrinology, Diabetes and Metabolism
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8706
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	Endocrinology, Diabetes and Metabolism
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8706
Homepage URL
Email	ahayashi@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine, Department of Endocrinology, Diabetes and Metabolism
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Soubudai Nieren clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Medical Ethics Organization
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel	042-778-8273
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	北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 25 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	138
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	During data analysis
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	Main results already published
Date of protocol fixation	2017 Year 10 Month 24 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 10 Month 24 Day
Last follow-up date	2018 Year 04 Month 26 Day
Date of closure to data entry	2019 Year 10 Month 10 Day
Date trial data considered complete	2019 Year 10 Month 17 Day
Date analysis concluded

Other
Other related information	Diabetic hemodialysis patients Continuous glucose monitoring Hemodialysis-related hypoglycemia Hemodialysis-induced glycemic disarrays

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2019 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033943