Determining the effect of insulin training on blood sugar control in patients with type 2 diabetes
Design
quasi-experimental study before and after on 400 patients with type 2 diabetes treated with insulin pen
Settings and conduct
Yazd Diabetes Center is study place . According to easy sampling, the samples are selected and entered into the study. The questionnaire is completed for all individuals who meet the inclusion criteria. Then, the face to face correct injection training is given to the people and an educational video will be provided to them in this regard. Questionnaires will be completed and analyzed three months after the last retraining session.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes who are referred to the Yazd Diabetes Center, who are being treated with insulin.
Inclusion criteria include: over 30 years of age, use of insulin pen for at least three months, insulin injection by a regular person. Exclusion criteria consist of dialysis patients, Missing training session, changing in the patient's daily insulin dose.
Intervention groups
The correct insulin injection technique is taught to each patient through face-to-face training.In order to remind the trained technique, an educational video has been prepared in this regard and provided to the participants via email or social networks or CDs. Symptoms of hypoglycemia and proper actions in hypoglycemia will be mentioned in video.
Main outcome variables
The daily dose of insulin received؛
The amount of fasting blood sugar؛
The amount of 2hpp
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200426047208N1
Registration date:2020-06-30, 1399/04/10
Registration timing:retrospective
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Akram Mehrabbeik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0226
Email address
mehrabbeyk@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of insulin injection training on blood glucose control among patients with type 2 diabetes
Public title
Effect of insulin injection training on blood glucose control among patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age >30
Use of insulin pen for at least three months
Insulin injection by a regular person
Exclusion criteria:
Dialysis patients
Miss training sessions
Changing in the patient's daily insulin dose
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Sq
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.SSU.REC.1398.213
Health conditions studied
1
Description of health condition studied
Insulin injection technique
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The daily dose of insulin received
Timepoint
At the beginning of the study (before intervention)and three months after the intervention
Method of measurement
Researcher-made questionnaire
2
Description
The amount of fasting blood sugar
Timepoint
At the beginning of the study (before intervention)and three months after the intervention
Method of measurement
Blood test
3
Description
The amount of 2hpp
Timepoint
At the beginning of the study (before intervention)and three months after the intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a face-to-face educational session by diabetes center training expert in the correct technique of insulin injection, emphasizing the cases in which the patient has insufficient skill and also display the correct insulin injection technique in the form of a 10-5 minute instructional video via email, CD or virtual networks as a reminder
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Akram Mehrabbeik
Street address
Talar Honar Alley- Bahonar Sq
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
info@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Bahonar Sq
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
Email
drc@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Akram Mehrabbeik
Position
کارشناس آموزش بهداشت
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Talar e honar alley,shahid saduqi blv
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۹۳۵۷۱
Phone
+98 35 3728 0226
Email
Mehrabbeyk@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Akram Mehrabbeik
Position
Health education expert
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
sadouqi blv. Talar honar alley
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۹۳۵۷۱
Phone
+98 35 3728 0226
Email
Mehrabbeyk@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Akram Mehrabbeik
Position
Health education expert
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Talar-e honar Alley. Sadouqi Blv
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۹۳۵۷۱
Phone
+98 35 3728 0226
Email
Mehrabbeyk@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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
Insulin injection technique in patients with type 2 diabetes
When the data will become available and for how long
3 months after the publication of the article
To whom data/document is available
Researchers and health educators
Under which criteria data/document could be used
More research or plan educational interventions
From where data/document is obtainable
Yazd University of Medical Sciences - Diabetes Research Center
What processes are involved for a request to access data/document
Research Director of Diabetes Research Center - Project Manager