UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060792 |
|---|---|
| Receipt number | R000069554 |
| Scientific Title | A Study on Glucose Control and Quality of Life Improvement in Type 1 Diabetes Patients Following Switching from SAP770G to 780G A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 01:58:35 |
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Basic information
Public title
A Study on Glucose Control and Quality of Life Improvement in Type 1 Diabetes Patients Following Switching from SAP770G to 780G A Prospective Observational Study
Acronym
SAP780G Switchover Study
Scientific Title
A Study on Glucose Control and Quality of Life Improvement in Type 1 Diabetes Patients Following Switching from SAP770G to 780G A Prospective Observational Study
Scientific Title:Acronym
SAP780G Switchover Study
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate changes in metabolic parameters, including blood glucose, and quality of life (QOL) indicators in type 1 diabetes patients currently undergoing insulin pump therapy with the 70G system, following their transition to the 780G system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average blood glucose from baseline 12 weeks after switching to 780G
Key secondary outcomes
Changes at 4 weeks, 12 weeks, and 24 weeks from the start of the study
Weight, waist circumference, BMI
Blood pressure, pulse rate
Other blood and urine tests
Daily blood glucose variability indices by treatment
24-hour average blood glucose
Percentage of time in target range (TIR; time spent within 70-180 mg/dL)
Length of time with blood glucose below 70 mg/dL (TBR; Percentage of time below target range)
Length of time with blood glucose above 180 mg/dL (TAR; Percentage of time above target range)
Daily blood glucose variability index
Hourly blood glucose AUC, MAGE, SD, MODD
Association with patient background and laboratory values affecting the above data
Patient questionnaires related to diabetes treatment satisfaction and QOL
Association with patient background and laboratory values affecting the above data
Patient background and clinical laboratory values affecting the above data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were a diagnosis of type 1 diabetes and treatment with the MiniMed 770G system.
Key exclusion criteria
Patients for whom participation in this study is difficult due to concomitant severe liver disease.
Patients deemed inappropriate for participation by the principal investigator or subinvestigators for any other reason.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | OE |
Organization
Kushiro Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
085-0032
Address
21-14 Shinei-cho, Kushiro, Hokkaido
TEL
0154-22-7171
o-e.yuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | OE |
Organization
Kushiro Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
085-0032
Address
21-14 Shinei-cho, Kushiro, Hokkaido
TEL
0154-22-7171
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Kushiro Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kushiro Red cross hospital
Address
21-14 Shinei-cho, Kushiro, Hokkaido
Tel
0154-22-7171
o-e.yuki@med.hokudai.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
| 2026 | Year | 03 | Month | 02 | 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 | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to evaluate changes in metabolic parameters, including blood glucose, and quality of life (QOL) indicators in type 1 diabetes patients currently on insulin pump therapy with the 770G system following a switch to the 780G system.
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069554
