UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050286 |
|---|---|
| Receipt number | R000057257 |
| Scientific Title | Effects of the MiniMed770G System Hybrid Closed Loop(HCL) |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/02/09 18:28:00 |
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Basic information
Public title
Effects of the MiniMed770G System Hybrid Closed Loop(HCL)
Acronym
Effects of the MiniMed770G System Hybrid Closed Loop(HCL)
Scientific Title
Effects of the MiniMed770G System Hybrid Closed Loop(HCL)
Scientific Title:Acronym
Effects of the MiniMed770G System Hybrid Closed Loop(HCL)
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 effects of HCL and related factors, we will examine glucose metabolism markers, CGM data, and insulin dose before and after the introduction of Minimed 770G automode in patients with type 1 diabetes who are undergoing sensor augmented pump (SAP) therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in TIR (70-180 mg/dL time)before and after introduction of HCL
Key secondary outcomes
TBR(time below renge)
TAR(time above range)
Average sensor glucose level
HbA1c
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
| 6 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
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)6 years old or older, under 85 years old
Key exclusion criteria
(1)Persons deemed inappropriate by the Principal Investigator or Research Assistants
(2)Patients who requested not to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Senoo |
Organization
Okayama Saiseikai General Hospital
Division name
internal medicine
Zip code
700-8511
Address
Okayama pre, Okayama city, kita-ku, kokutai-cho 2-25
TEL
086-252-2211
qoomym@gmail.com
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Tone |
Organization
Okayama Saiseikai General Hospital
Division name
internal medicine
Zip code
700-8511
Address
Okayama pre, Okayama city, kita-ku, kokutai-cho 2-25
TEL
086-252-2211
Homepage URL
aitone@ms1.megaegg.ne.jp
Sponsor or person
Institute
Okayama Saiseikai General 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
Okayama Saiseikai General Hospital
Address
Okayama pre, Okayama city, kita-ku, kokutai-cho 2-25
Tel
086-252-2211
chiken-hp@okayamasaiseikai.or.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
| 2023 | Year | 02 | Month | 09 | 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
37
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We determine the effects of the MiniMed770G System Hybrid Closed Loop(HCL).
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057257
