![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000001525 |
Receipt No. | R000001841 |
Scientific Title | Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose |
Date of disclosure of the study information | 2009/01/01 |
Last modified on | 2008/11/25 |
Basic information | ||
Public title | Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose | |
Acronym | Compliance of SMBG and blood glucose control | |
Scientific Title | Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose | |
Scientific Title:Acronym | Compliance of SMBG and blood glucose control | |
Region |
|
Condition | ||
Condition | Type 2 diabetes | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate if reduction of pain by blood sampling from flat of a hand in Self-Monitoring of Blood Glucose (SMBG) affects compliance of SMBG and control of blood glucose |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1) Level of HbA1c reduction
2) Number of times of SMBG (Compliance) |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 5 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
|
||
Interventions/Control_1 | Blood sampling from flat of a hand drugs
|
||
Interventions/Control_2 | Blood sampling from a finger tip | ||
Interventions/Control_3 | No operation of SMBG | ||
Interventions/Control_4 | Treatment by only oral anti-diabetic drugs
|
||
Interventions/Control_5 | Treatment by insulin | ||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. Type 2 DM
2. No experience of SMBG within 1 year 3. Patients who can do SMBG 4. HbA1c≥5.8%, or FBS≥110mg/dl 5. No improvement by0.5% or more in HbA1c in 3 months 6. 20 years old or more 7. Male or female 8. Patients who can agree with written consent |
|||
Key exclusion criteria | 1. Type 1 DM or secondary diabetes
2. Patients who performed SMBG in 1 year 3. Improvement by 0.5% or more in HbA1c in 3 months 4. Patients who have depression, psychiatric diseases and alcoholism 5. Patients who have malignant cancers 6. Patients who have abnormal hemoglobin 7. Patients who are not permitted to participate in this trial by attending doctors |
|||
Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Graduate School of Medicine, Kyoto University | ||||||
Division name | Department of Diabetes and Clinical Nutrition | ||||||
Zip code | |||||||
Address | Syogoin Kawahara-cho 54, Sakyo-ku, Kyoto-city, Kyoto, Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Graduate Shcool of Medicine, Kyoto University | ||||||
Division name | Department of Diabetes and Clinical Nutrition | ||||||
Zip code | |||||||
Address | |||||||
TEL | 075-751-3560 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Dapartment of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto Universiy |
Institute | |
Department |
Funding Source | |
Organization | Johnson and Johnson |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001841 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |