UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048743 |
|---|---|
| Receipt number | R000055533 |
| Scientific Title | Research on factors that determine the effectiveness of diabetes treatment |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2023/03/28 08:49:36 |
* 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
Research to explore the causes of individual differences in the effectiveness of diabetes treatment
Acronym
Individual differences in diabetes treatment
Scientific Title
Research on factors that determine the effectiveness of diabetes treatment
Scientific Title:Acronym
Factors determining the effectiveness of diabetes treatment
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In outpatient care, the degree of decrease in HbA1c varies from individual to individual even when the same diabetes treatment is used. The purpose of this study is to clarify whether this difference is due to the materials used or psychological factors of individual patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemoglobin A1c
BSCS-J scale score
Scores on the HOPE Scale
Self-stigma scale score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. The degree of decrease in HbA1c is calculated after 6 months of nutritional guidance and other treatments. Meanwhile, CGM records will be used to create a teaching material summarizing the relationship between blood glucose fluctuations and daily life. Using this educational material as well, the degree of decrease in HbA1c will be calculated after 6 months of nutritional guidance and other treatments.The degree of decrease in HbA1c will be compared between these two groups.
Interventions/Control_2
2. We will examine the relationship between the degree of decline in HbA1c and the scores on the three scales (Japanese version of the Self-Stigma Scale, Japanese version of the Hope Scale, and a shortened version of the Self-Control Scale).
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
| 76 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes who were attending our diabetes center and whose average HbA1c over 3 months was less than 7.1% and more than 6.3% without changing the treatment plan.
Key exclusion criteria
Patients over 76 years old
Patients undergoing psychosomatic treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Kuwajima |
Organization
The Taijyu-kai Foundation(Social medical corporation) Kaisei General Hospital
Division name
Diabetes Medicine
Zip code
762-0007
Address
Muromachi 3chome5-28,Sakaide City Kagawa Prefecture,Japan
TEL
+81-877-46-1011
kuwajima@kaisei.or.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Kuwajima |
Organization
The Taijyu-kai Foundation(Social medical corporation) Kaisei General Hospital
Division name
Diabetes Medicine
Zip code
762-0007
Address
Muromachi 3chome5-28,Sakaide City Kagawa Prefecture,Japan
TEL
+81-877-46-1011
Homepage URL
kuwajima@kaisei.or.jp
Sponsor or person
Institute
The Taijyu-kai Foundation(Social medical corporation) Kaisei General Hospital
Diabetes Medicine
Institute
Department
Personal name
Funding Source
Organization
The Taijyu-kai Foundation(Social medical corporation) Kaisei General Hospital
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
The Taijyu-kai Foundation(Social medical corporation) Kaisei General Hospital,ethics review committee
Address
Muromachi 3chome5-28,Sakaide City Kagawa Prefecture,Japan
Tel
+81-877-46-1011
mail00@kaisei.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 | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
HbA1c In the CGM group, pre-intervention value was 6.6. The post-intervention value was 6.5. There was significant decrease between two values(p=0.049).In the control group, pre-intervention value was 6.7. The post-intervention value was 6.5. There was significant decrease between two values (p=0.008).The difference between pre-and post- intervention value was 0.2 in the CGM group. In the control group the value was 0.2. There was no difference between two groups (p=0.840).
Results date posted
| 2023 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Lead principal investigator has been sick.
Date of the first journal publication of results
Baseline Characteristics
There was no difference in age, sex, disease duration, BMI, eGFR, and retinopathy between the CGM group and the control group.
Participant flow
Patients who had not yet established appropriate lifestyle habits and who accepted the CGM equipment within 4 months prior to intervention were considered to be in the CGM group (n=8), while those who did not accept the CGM equipment were considered to be in the control group (n=12). Oral hypoglycemic agents and insulin were not changed during the entire course of the study (3 months before intervention, intervention for 6 months, and 2 months after intervention). Patients visited the hospital once a month. Nutritional and lifestyle guidance was given every month for 6 times. The difference between pre-and post-intervention value was defined as the primary end point. The mean HbA1c value for 3 months before intervention and the first day of intervention was used as the pre-intervention value, and the HbA1c value one month after the sixth guidance session was used as the post-intervention value.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055533
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
