UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047394 |
|---|---|
| Receipt number | R000053968 |
| Scientific Title | Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients with Type 1 Diabetes |
| Date of disclosure of the study information | 2022/04/05 |
| Last modified on | 2024/07/17 13:34:57 |
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Basic information
Public title
Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients with Type 1 Diabetes
Acronym
Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients with Type 1 Diabetes
Scientific Title
Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients with Type 1 Diabetes
Scientific Title:Acronym
Efficacy and Psychological Effects of MiniMed 770G (Hybrid Closed-loop system) in Patients 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
To determine the usefulness of switching to MiniMed 770G (insulin pump with hybrid closed-loop system) for glycemic control in Japanese patients with type 1 diabetes. In addition, we will examine the factors associated with efficacy and the psychological effects after the change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in sensor glucose level from 70 to 180 mg/dL of time at CGM between baseline and end of observation (after 24 weeks of switching).
Key secondary outcomes
(1) Change in each of the following items from baseline to the end of observation (after 24 weeks of changeover)
HbA1c
Percentage of time that sensor glucose level is higher than 181 mg/dL and higher than 251 mg/dL at CGM.
Percentage of time that sensor glucose level is less than 70 mg/dL and less than 54 mg/dL at CGM.
Average sensor glucose level and coefficient of variation during the period of CGM
Number of hypoglycemia alerts and hyperglycemia alerts
Average daily insulin dose and average daily basal insulin dose
Scores of various questionnaires (CSII-QOL, DTSQ, PAID)
(2) Amount of change in the percentage of HbA1c less than 7% achieved between baseline and the end of observation (after 24 weeks of switching)
(3) Time of wearing CGM and using Hybrid closed-loop system
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) Type 1 diabetes treated sensor-augmented pump
(2) Patients whose insulin pump will be changed to MiniMed 770G
(3) 18 years and older
(4) Patients with written consent
Key exclusion criteria
(1) Patients with cancer
(2) Patients on steroid treatment
(3) Persons deemed inappropriate by the Principal Investigator or Research Assistants
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kubota |
Organization
Shinshu University Hospital
Division name
Diabetes Endocrinology
Zip code
390-8621
Address
Nagano pre, Matsumoto city, asahi 3-1-1
TEL
0263-35-4600
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
Zip code
390-8621
Address
Nagano pre,Matsumoto city,asahi 3-1-1
TEL
0263-35-4600
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 Hospital
Address
Nagano pre, Matsumoto city, asahi 3-1-1
Tel
0263-35-4600
skubota@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ24-0136/_article/-char/en
Number of participants that the trial has enrolled
25
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the effectiveness of glycemic control and psychological impact at 24 weeks after the change of MiniMed 770G (Hybrid closed-loop system).
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053968
