UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048859 |
|---|---|
| Receipt number | R000055666 |
| Scientific Title | effectiveness of sensor-augmented insulin-pump by changing MiniMed 770G in type 1 diabetes patients |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2026/03/11 15:58:14 |
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Basic information
Public title
effectiveness of sensor-augmented insulin-pump by changing MiniMed 770G in type 1 diabetes patients
Acronym
effectiveness of sensor-augmented insulin-pump by changing MiniMed 770G in type 1 diabetes patients
Scientific Title
effectiveness of sensor-augmented insulin-pump by changing MiniMed 770G in type 1 diabetes patients
Scientific Title:Acronym
effectiveness of sensor-augmented insulin-pump by changing MiniMed 770G in type 1 diabetes patients
Region
| Japan |
Condition
Condition
type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of minimed770G
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the change from baseline body weight, glucose variability and insulin units.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Change from 640 to 770.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with type 1 diabetes using minimed 770
Key exclusion criteria
The patients with type 2 diabetes and gestational diabetes
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Fuchigami |
| Middle name | |
| Last name | Ayako |
Organization
Toho University Graduate School of Medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Departmet of Medicine
Zip code
143-8541
Address
6-11-1Omori-Nishi,Ota-ku,Tokyo
TEL
03-3762-4151
ayako.fuchigami@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Fuchigami |
| Middle name | |
| Last name | Ayako |
Organization
Toho University Graduate School of Medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Departmet of Medicine
Zip code
143-8541
Address
6-11-1Omori-Nishi,Ota-ku,Tokyo
TEL
03-3762-4151
Homepage URL
ayako.fuchigami@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University Graduate School of Medicine
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
Toho University Graduate School of Medicine
Address
6-11-1Omori-Nishi,Ota-ku,Tokyo
Tel
0337624151
ayako.fuchigami@med.toho-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 | 09 | Month | 12 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s13340-024-00778-7
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13340-024-00778-7
Number of participants that the trial has enrolled
14
Results
This study evaluated glycemic variability and quality of life in Japanese individuals with type 1 diabetes after switching from MiniMed 640G to MiniMed 770G. After the transition, Time in Range improved and the proportion of patients achieving TIR 70% increased. In addition, mean sensor glucose levels decreased, indicating reduced hyperglycemia. However, no significant changes were observed in total daily insulin dose, or DTR-QOL scores.
Results date posted
| 2026 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 24 | Day |
Baseline Characteristics
A total of 14 Japanese individuals with type 1 diabetes were included in this study. The mean age was 46.9 years, and 78.6% of participants were female. The mean duration of diabetes was 8.3 years, the baseline HbA1c was 7.52%, and the mean body mass index was 21.8 kg/m2.
Participant flow
In this study, individuals with type 1 diabetes who had been using a predictive low-glucose suspend insulin pump system (MiniMed 640G) were transitioned to a hybrid closed-loop system (MiniMed 770G). Glycemic outcomes and quality of life were assessed at baseline and at 3 and 12 months after the transition, and a total of 14 participants were included in the final analysis.
Adverse events
No serious adverse events were observed during the study period. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred. In addition, no serious device-related adverse events were reported.
Outcome measures
The primary outcome of this study was the change in Time in Range (TIR) after switching to the hybrid closed-loop system. Secondary outcomes included continuous glucose monitoring metrics such as mean sensor glucose, Time Above Range (TAR), and Time Below Range (TBR), as well as quality of life assessed using the DTR-QOL questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055666
