UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034234 |
|---|---|
| Receipt number | R000039028 |
| Scientific Title | Sensor-augmented pump therapy for pancreatogenic diabetes after total pancreatectomy : a prospective observational study |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/06/24 19:58:01 |
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Basic information
Public title
Sensor-augmented pump therapy for pancreatogenic diabetes after total pancreatectomy : a prospective observational study
Acronym
Sensor-augmented pump therapy for pancreatogenic diabetes after total pancreatectomy : a prospective observational study
Scientific Title
Sensor-augmented pump therapy for pancreatogenic diabetes after total pancreatectomy : a prospective observational study
Scientific Title:Acronym
Sensor-augmented pump therapy for pancreatogenic diabetes after total pancreatectomy : a prospective observational study
Region
| Japan |
Condition
Condition
Pancreatogenic diabetes
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of sensor-augmented insulin pump for pancreatogenic diabetes after total pancreatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the percentage of time that glucose values are within the target range (70 to 180 mg/dL)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sensor-augmented insulin pump, 1 year.
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
1. postoperative patient over 6 months after total pancreatectomy who isn't properly controlled in blood sugar
2. Performance Status 0, 1
Key exclusion criteria
1. the patient who is difficult to do insulin self-injection
2. the patient who has another cancer
3. the patient who has active infection
4. pregnancy
5. the patient who received steroid medication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177205
m_unno@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Iseki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
0227177205
Homepage URL
isekimasahiro@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Surgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039028
