Comparison of the effect of self-assessment of blood glucose on glycosylated hemoglobin levels in elderly patients with type 2 diabetic
Design
In this study, 150 elderly patients with type 2 diabetes will be divided in to two groups randomly. Intervention group are elderly patients with type 2 diabetes who perform self-assessment. and control group are elderly patients who do not perform self assessment.
Settings and conduct
In this randomized control trial , 150 elderly patients with type 2 diabetes will be divided in to two groups randomly regard to random block and table method. Intervention group are elderly patients with type 2 diabetes who perform self-assessment. and control group are elderly patients who do not perform self assessment.Physicians and data collector will be unaware of self assessment.
Participants/Inclusion and exclusion criteria
Inclusion criteria are type 2 diabetes, agreement to participate in the research and Glycosylated hemoglobin between 7 and 9%.
Exclusion criteria are other chronic diseases including cancer, renal failure, hepatic and heart failure-2 inflammatory diseases, rheumatoid arthritis, Major Depression, other endocrine disorders, Cushing's syndrome and hematologic disorders.
Intervention groups
Intervention group:
elderly patients with type 2 diabetes who perform self-assessment.
Control group: Elderly diabetic patients who do not perform self-assessment of blood glucose.
Main outcome variables
Glycosylated hemoglobin (HbA1C)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038055N1
Registration date:2018-06-05, 1397/03/15
Registration timing:registered_while_recruiting
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Atousa Ariafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3512
Email address
ariafara2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-07-20, 1397/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Self Monitoring of Blood Glucose (SMBG) on glycosylated hemoglobin level in elderly patients with type 2 diabetes mellitus
Public title
Self Monitoring of Blood Glucose (SMBG) in elderly patients with type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes
agreement to participate in the research
Glycosylated hemoglobin between 7 and 9%
Exclusion criteria:
Infection with other chronic diseases including cancer, severe renal failure, severe liver and heart failure
Inflammatory diseases, including rheumatoid arthritis
Major Depression
Other endocrine disorders, including Cushing's
Blood disorders and the need for several blood transfusion
Age
From 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to diabetes clinic in Sabzevar will be randomly divided into two groups based on random block method and tables.
Blinding (investigator's opinion)
Single blinded
Blinding description
Physicians and data collector will be unaware of self assessment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Asadabadi blvd; sabzevar
City
Mashhad
Province
Razavi Khorasan
Postal code
9613873119
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MEDSAB.1396.118
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
Before the intervention, 120 days after self-assessment of blood glucose
Method of measurement
The test for hemoglobin A1c will be performed by chromatography.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-assessment of blood glucose in elderly diabetic patients treated with insulin .
Category
Behavior
2
Description
Control group: Elderly diabetic patients who do not perform self-assessment of blood glucose.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Diabetes Clinic
Full name of responsible person
atousa ariafar
Street address
asadabadi street; 1specefic clinic;
City
Mashhad
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4422 0869
Email
ariafara2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh ghorat
Street address
shohadai hasteii Blvd., Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4422 0869
Email
VCResearch@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
atousa ariafar
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebnesina street; Emamreza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 3512
Email
ariafara2@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atousa Ariafar
Position
Head nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebnesina street; Emamreza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 3512
Email
ariafara2@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atousa Ariafar
Position
Head nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebnesina street; Emamreza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 3512
Email
ariafara2@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The mean values of glycosylated hemoglobin, demographic variables and their relationship will be shared in the final article.
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
The type of analysis, method of use and results should be specified.
From where data/document is obtainable
Author of the article and author of the first article
assarroudia@medsab.ac.ir
ariafara2@mums.ac.ir
What processes are involved for a request to access data/document
send mail
Detailed explanation of the required data
The reason for the data requirement