UMIN-CTR Clinical Trial

Basic information
Public title	A novel combination therapy with telemonitoring and individual insulin titration system for diabetes mellitus
Acronym	NOCTIS
Scientific Title	A novel combination therapy with telemonitoring and individual insulin titration system for diabetes mellitus
Scientific Title:Acronym	NOCTIS
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of the combination therapy with telemonitoring and individual insulin titration system (NOCTIS)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes

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	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	Using the combination therapy with telemonitoring and individual insulin titration system (NOCTIS) during four months
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	(a) Diabetes (over 20 and under 75 years of age) (b) patients who regularly use self-care insulin (c) HbA1c (NGSP) over 7.0% and under 10.0% (d) using self monitoring of blood glucose (e) patients who are able to visit our hospital every month (f) having e-mail address and mobile phone (g) patients who have received adequate explanation of the contents of the trial and given their written consent.
Key exclusion criteria	a) having severe renal dysfunction (serum Cr > 2.5 mg/dl) b) having severe liver dysfunction (3 X the upper limit of normal) c) having severe infection, severe trauma, or pre and post operation d) having diabetic ketosis, diabetic coma, or insulin-dependent diabetes mellitus e) heavy drinker f) being pregnant g) having malignancy h) having visual disorder i) being unsuitable for participation in the trial for any reason, according to the investigators
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Iuchi Middle name Last name Hiroyuki
Organization	The Jikei University Katsushika Medical Center
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code	105-8461
Address	6-41-2, Aoto, Katsushika-ku, Tokyo
TEL	03-3603-2111
Email	h-iuchi@jikei.ac.jp

Public contact
1st name of contact person	1st name Iuchi Middle name Last name Hiroyuki
Organization	The Jikei University Katsushika Medical Center
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code	105-8461
Address	6-41-2, Aoto, Katsushika-ku, Tokyo
TEL	03-3603-2111
Homepage URL
Email	h-iuchi@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	The Jikei University School of Medicine
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel	03-3433-1111
Email	rinri@jikei.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	2018 Year 06 Month 16 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	15
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	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 04 Month 10 Day
Anticipated trial start date	2018 Year 06 Month 16 Day
Last follow-up date	2019 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 16 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037647