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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034234
Receipt No. 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

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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
Email 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
Email isekimasahiro@surg.med.tohoku.ac.jp

Sponsor
Institute Department of Surgery, Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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