UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033024
Receipt No. R000037647
Scientific Title A novel combination therapy with telemonitoring and individual insulin titration system for diabetes mellitus
Date of disclosure of the study information 2018/06/16
Last modified on 2019/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.