UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030947 |
|---|---|
| Receipt number | R000035098 |
| Scientific Title | Efficacy of insulin patch pump in patients with type 1 diabetes |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/01/09 15:40:01 |
* 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
Efficacy of insulin patch pump in patients with type 1 diabetes
Acronym
Efficacy of insulin patch pump
Scientific Title
Efficacy of insulin patch pump in patients with type 1 diabetes
Scientific Title:Acronym
Efficacy of insulin patch pump
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to analyze the changes in blood glucose control and insulin dose in patients with type 1 diabetes mellitus undergoing basal-bolus therapy or continuous insulin pump therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Glycated albumin, blood glucose fluctuation parameters obtained by continuous glucose monitoring.QOL, total daily dose of insulin, urinary albumin excretion rate, and body weight
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
Switching from multiple daily insulin injection or continuous subcutaneous insulin infusion to insulin patch pump therapy.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. HbA1c under 10%
2. Measuring their blood glucose two or more times per day
Key exclusion criteria
1. Severe hepatic and/or renal impairment
2. Severe infection
3. Perioperative status
4. Severe trauma
5. Pregnancy or a desire to become pregnant
6. Cancer
7. Other reasons leading the physician in charge to judge that the patient was unsuitable.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Koyama |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
ykusu@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kusunoki |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
Homepage URL
ykusu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College 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
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 | 02 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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 | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
