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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037177 |
Receipt No. | R000042367 |
Scientific Title | Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes. |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2020/12/27 |
Basic information | ||
Public title | Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes. | |
Acronym | Appropriate glycemic goals in elderly patients with diabetes | |
Scientific Title | Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes. | |
Scientific Title:Acronym | Appropriate glycemic goals in elderly patients with diabetes | |
Region |
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Condition | ||
Condition | Diabetes | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of our study is to investigate the agreement between measured HbA1c and HbA1c goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes. |
Basic objectives2 | Others |
Basic objectives -Others | The aim of our study is to evaluate the association between the agreement for glycemic goals based on DASC-8 and diabetes-related complications in elderly patients with diabetes. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Agreement between HbA1c goals based on DASC-8 and measured HbA1c |
Key secondary outcomes | The association between agreement for HbA1c goals based on DASC-8 and clinical characteristics, glucose-related parameters or insulin secretion
The association between the physical condition evaluated by DASC-8 and diabetes-related complications |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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Interventions/Control_4 | |
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Interventions/Control_6 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) 65 years of age or more
2) Patients with diabetes 3) Written informed consent |
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Key exclusion criteria | 1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months
2) Patients with serious infectious disease, before operation, serious trauma in the past 6 months 3) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido University Hospital | ||||||
Division name | Internal Medicine II | ||||||
Zip code | 060-8638 | ||||||
Address | North 14, West 5, Kita-ku, Sapporo, Hokkaido | ||||||
TEL | 011-706-5915 | ||||||
akinbo@tim.hi-ho.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido University Hospital | ||||||
Division name | Internal Medicine II | ||||||
Zip code | 060-8638 | ||||||
Address | North 14, West 5, Kita-ku, Sapporo, Hokkaido | ||||||
TEL | 011-706-5915 | ||||||
Homepage URL | |||||||
akinbo@tim.hi-ho.ne.jp |
Sponsor | |
Institute | Hokkaido University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Hokkaido University Hospital |
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 | Hokkaido University Hospital Clinical Research and Medical Innovation Center |
Address | North 14, West 5, Kita-ku, Sapporo, Hokkaido |
Tel | 011-706-7061 |
none@none |
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 | 北海道大学病院(北海道)
NTT東日本札幌病院(北海道) 萬田記念病院(北海道) 帯広厚生病院(北海道) 釧路赤十字病院(北海道) 苫小牧市立病院(北海道) 北海道中央労災病院(北海道) 沖医院(北海道) 栗原内科(北海道) さっぽろ糖尿病・甲状腺クリニック(北海道) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | This is as observational study. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042367 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |