UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062158 |
|---|---|
| Receipt number | R000071131 |
| Scientific Title | Evaluation of Patient-Participatory Multidisciplinary Conferences in Diabetes Care |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2026/07/07 14:29:18 |
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Basic information
Public title
Evaluation of Patient-Participatory Multidisciplinary Conferences in Diabetes Care
Acronym
PPMC-DM Study
Scientific Title
Evaluation of Patient-Participatory Multidisciplinary Conferences in Diabetes Care
Scientific Title:Acronym
PPMC-DM Study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of patient-participatory multidisciplinary conferences compared with conventional conferences on glycemic control, clinical parameters, patient-reported outcomes, healthcare professional assessments, and qualitative outcomes in patients admitted for diabetes education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
Glycemic variability metrics assessed by continuous glucose monitoring (CGM), including Time in Range (TIR) and coefficient of variation (CV)
Body weight, blood pressure, serum lipid profile, renal function, and liver function
Patient-reported outcomes (quality of life, quality of decision-making, treatment satisfaction, and psychological burden)
Healthcare professional assessment (modified ATHCTS)
Qualitative evaluation (analysis of conference proceedings and interview data)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patient-participatory multidisciplinary conferences will be conducted for hospitalized patients with diabetes. Patients will participate in multidisciplinary conferences together with healthcare professionals, including physicians, nurses, registered dietitians, and pharmacists, to share information and discuss their medical condition, self-management issues, and treatment plans.
Interventions/Control_2
Conventional multidisciplinary conferences will be conducted for hospitalized patients with diabetes. Healthcare professionals, including physicians, nurses, registered dietitians, and pharmacists, will discuss the patient's medical condition, self-management issues, and treatment plans without patient participation.
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
[Patients]
1)Patients aged 18 years or older
2)Patients with diabetes
3)Hospitalized patients
4)Patients who provide written informed consent to participate in the study
[Healthcare professionals]
1)Healthcare professionals involved in the diagnosis, care support, or treatment planning of eligible patients and participating in the study conferences
2)Healthcare professionals who provide written informed consent to participate in the study
Key exclusion criteria
[Patients]
1)Patients with severe visual impairment due to diabetic retinopathy or other causes.
2)Patients diagnosed with dementia.
3) Patients judged to be unsuitable for participation by a physician.
[Healthcare professionals]
1)Healthcare professionals unable to complete the questionnaire or participate in the interview.
2) Healthcare professionals judged to be unsuitable for participation by a physician.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Gunma University Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
3718511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8122
smatsu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Gunma University Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8133
Homepage URL
smatsu@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-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
| 2026 | Year | 07 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071131
