UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033024 |
|---|---|
| Receipt number | 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 15:08:16 |
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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
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
h-iuchi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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