UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055962 |
|---|---|
| Receipt number | R000063820 |
| Scientific Title | A fact-Finding Survey on the Treatment and Environment for Older Adults with Type 1 Diabetes |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2025/10/30 17:27:49 |
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Basic information
Public title
A fact-Finding Survey on the Treatment and Environment for Older Adults with Type 1 Diabetes
Acronym
A fact-Finding Survey on the Treatment and Environment for Older Adults with Type 1 Diabetes
Scientific Title
A fact-Finding Survey on the Treatment and Environment for Older Adults with Type 1 Diabetes
Scientific Title:Acronym
A fact-Finding Survey on the Treatment and Environment for Older Adults with Type 1 Diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to carry out on Type 1 diabetes who use insulin pumps, their families, healthcare professionals and welfare facilities for the older adults to clarify the actual conditions of treatment, including the psychological aspects, of the older adults with Type 1 diabetes. Furthermore, the actual conditions and problems of the treatment, medical environment and social environment surrounding the older adults with type 1 diabetes will be clarified.
Basic objectives2
Others
Basic objectives -Others
1. We will investigate blood glucose-related indicators (HbA1c, GA, mean sensor glucose level, GMI, %CV, TIR, TAR, TBR,TITR, sensor usage) as part of the participants background.
2. We will investigate the actual state of treatment, including psychological aspects of participants, by assessing quality of life using PAID and DTSQ.
3. We will investigate cognitive and life function assessments on participants (DASC-21).
4. We will conduct a questionnaire survey of participants, healthcare professionals and welfare facilities for the older adults to investigate the actual conditions of treatment and environment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
CSII-QOL in the older adults with type 1 diabetes
Key secondary outcomes
(1) Blood glucose-related indicators (HbA1c, GA, mean sensor glucose level, GMI, %CV, TIR, TAR, TBR, TITR, sensor usage)
(2) CSII-QOL, PAID, DTSQ (quality of life for people aged 40-64 and 65+)
(3) Cognitive and lifestyle function assessment (DASC-21)
(4) Questionnaires
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
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who meet all of the following selection criteria and none of the exclusion criteria will be included in the study
1. Participants
(1) Persons with type 1 diabetes attending or being admitted to this hospital
(2) Age 40 years or older at the time consent is obtained.
(3) Insulin pump users (those receiving insulin pump therapy for the treatment of type 1 diabetes at the Department of Diabetes and Endocrinology, Kobe University Hospital during the study period after the date of approval to conduct the study by the director of the research institute).
2. Medical personnel
(1) Doctors, nurses and dietitians.
(2) Persons involved in diabetes care.
3. Welfare facilities for the older adults.
(1) Welfare facilities in Hyogo Prefecture.
Key exclusion criteria
1. Participants
(1) Persons who do not intend to give their consent.
(2) Persons deemed by the principal investigator to be unsuitable as subjects for this study.
2. Medical personnel
(1) Persons who are judged by the principal investigator to be unsuitable as subjects of this study.
3. Welfare facilities for the elderly
(1) Persons who are judged by the principal investigator to be unsuitable as subjects of this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Medicine, Department of Internal Medicine Division of Diabetes and Endocrinology
Division name
Kobe University Graduate School of Medicine, Department of Internal Medicine Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken, 650-0017 Japan
TEL
078-382-5861
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mei |
| Middle name | |
| Last name | Nakatsuji |
Organization
Kobe University of Medicine, Department of Internal Medicine Division of Diabetes and Endocrinology
Division name
Kobe University of Medicine, Department of Internal Medicine Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken, 650-0017 Japan
TEL
078-382-5861
Homepage URL
meeei507@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Ltd.
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
Kobe University Graduate School of Medicine, Department of Internal Medicine Division of Diabetes and Endocrinology
Address
7-5-1 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken, 650-0017 Japan
Tel
078-382-5861
hirota@med.kobe-u.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
| 2024 | Year | 12 | Month | 25 | 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
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation and examination schedule
(1) Participants.
We will collect questionnaires, such as quality of life assessments, cognitive function assessments and life function assessments as questionnaires for patients, on the day of the outpatient visit and by the next day of the outpatient visit.
(2) Healthcare professionals; (3) Welfare facilities
We will collect questionnaires for healthcare professionals and the welfare facilities within a timeframe (approximately two months). The response method is web-based or paper-based.
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063820
