UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048447 |
|---|---|
| Receipt number | R000055195 |
| Scientific Title | Survey of hypoglycemia unawareness using CGM in type 2 diabetes with high risk of severe hypoglycemia |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/22 14:26:03 |
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Basic information
Public title
Survey of hypoglycemia unawareness using CGM in type 2 diabetes with high risk of severe hypoglycemia
Acronym
Hypoglycemia unawareness using CGM in type 2 diabetes
Scientific Title
Survey of hypoglycemia unawareness using CGM in type 2 diabetes with high risk of severe hypoglycemia
Scientific Title:Acronym
Hypoglycemia unawareness using CGM in type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with type 2 diabetic who are at high risk of severe hypoglycemia, we clarify the clinical characteristics of cases that cause hypoglycemia, and use CGM to determine the time zone when hypoglycemia occurs frequently and glucose profile even if it does not become severe.
Basic objectives2
Others
Basic objectives -Others
We evaluate the relationship between CGM data and medical information (age, height, weight, gender, duration, complications such as retinopathy, nephropathy, neuropathy, hypertension, dyslipidemia, HbA1c, eGFR).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time below range (level 1; glucose < 56 mg/dL, and 2; glucose < 54 mg/dL) during whole day, day time and night time.
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes with high risk of severe hypoglycemia: 65 years or older, HbA1c <7.5%, treatment with Sulfonyl Urea or insulin.
Supplement: Decreased renal function (eGFR <60 ml / min / 1.73 m2), history of severe hypoglycemia, It is even more desirable if there is hypoglycemia unawareness.
Key exclusion criteria
Current treatment with CGM.
Skin trouble due to CGM in the past
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Munehide |
| Middle name | |
| Last name | Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima
TEL
0886337587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Munehide |
| Middle name | |
| Last name | Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima
TEL
0886337587
Homepage URL
matuhisa@tokushima-u.ac.jp
Sponsor or person
Institute
Japan Diabetes Society
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee at the Japan Diabetes Society
Address
Wajyun Bild. 2F, 2-22-2 Koishikawa, Bunkyo-ku, Tokyo
Tel
03-3815-4364
harada@jds.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4118
Org. issuing International ID_1
Ethical committee at the Tokushima University Hospital,
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳島大学病院他 80施設
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 26 | 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
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-invasive clinical trials
Management information
Registered date
| 2022 | Year | 07 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055195
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
