UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053373 |
|---|---|
| Receipt number | R000060795 |
| Scientific Title | Efficacy and Psychological Impact of Advanced Hybrid Closed-Loop for Type 1 Diabetes in Japanese |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/31 14:51:34 |
* 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 and Psychological Impact of Advanced Hybrid Closed-Loop for Type 1 Diabetes in Japanese
Acronym
Efficacy of AHCL for Type 1 Diabetes in Japanese
Scientific Title
Efficacy and Psychological Impact of Advanced Hybrid Closed-Loop for Type 1 Diabetes in Japanese
Scientific Title:Acronym
Efficacy of AHCL for Type 1 Diabetes in Japanese
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine the efficacy of the Advanced Hybrid Closed-Loop on glycemic control in Japanese people with type 1 diabetes.
We will also study the psychological impact after the change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to end of follow-up (at 26 weeks) in the percentage of time that the sensor glucose level was from 70 to 180 mg/dL.
Key secondary outcomes
(1) Baseline and end of follow up data for the following items
Percentage of time with sensor glucose levels greater than 181 mg/dL and greater than 251 mg/dL
Percentage of time with sensor glucose levels less than 70 mg/dL and less than 54 mg/dL
Mean, coefficient of variation, and glucose control indicator values for sensor glucose values
Glycemia risk index
Average daily insulin dose, average daily bolus insulin dose, and average daily basal insulin dose
HbA1c
Questionnaire scores (DTSQs, DTSQc, PAID, CSII-QOL, HFS)
(2) CGM logging time and AHCL operating time, number of AHCL suspensions
(3) Average number of blood glucose measurements per day
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)18 years of age or older
(2)Patients diagnosed with type 1 diabetes
(3)Patients receiving SAP therapy for more than 3 months
(4)Patients starting to use AHCL
(5)Patients with written informed consent
Key exclusion criteria
(1) Patients with cancer
(2) Patients receiving systemic steroids
(3) Pregnant or lactating women
(4) Patients deemed unsuitable as subjects by the principal investigator or research assistant
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kubota |
Organization
Shinshu University Hospital
Division name
Diabetes, Endocrinology and Metabolism
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
TEL
+81263354600
skubota@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kubota |
Organization
Shinshu University Hospital
Division name
Diabetes, Endocrinology and Metabolism
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
TEL
+81263354600
Homepage URL
skubota@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
Tel
+81263372572
mdrinri@shinshu-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
長野赤十字病院（長野県）、長野県厚生農業協同組合連合会南長野医療センター篠ノ井総合病院（長野県）、佐久市立国保浅間総合病院（長野県）、松本協立病院（長野県）、長野県厚生農業協同組合連合会佐久総合病院佐久医療センター（長野県）
Other administrative information
Date of disclosure of the study information
| 2024 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter, single-arm, prospective observational study.
During the observation period, patients will be treated as usual.
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
