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Comparison of 32-Gauge with 4-mm Pen Needle and 8-mm Pen Needle efficiency on Glycemic Control, leakage, and pain in Type 2 diabetes Patients Referred to Razi Therapeutic and Educational Hospital, Rasht-2017

Protocol summary

Study aim
Determination of impact of Gauge-32 needles application with 4 and 8 mm lengths and the position of injection in the pain level, leakage after injection and blood sugar control of the patients with diabetes type II.
Design
In this research, the researched units with 207 individuals, are divided to two groups based on Random allocation rule and in one group, Gauge-32 with 4 mm length is used for injection and in another group, Gauge-32 with 8 mm length is used. Then based on crossover method, the used needles are substituted in each group with one another.
Settings and conduct
The injection is done by the researcher and the time of injection is chosen based on routine hospital ward. The researchers after their introduction to the educational and therapeutic center and refer to department of endocrinology and rheumatology of this center and after achieving agreement from the studied units, they started the process of the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients with diabetes type II, age between 18-75, the diagnosis of diabetes type II, insulin injection at least for 2 years, BMI more than 18.5, no mental retardation and mental disorders and application of insulin is through insulin pen and exclusion criteria: no interest for participation in the research, no diabetes and suffering from skin disorders around the injection position.
Intervention groups
The effect of Gauge-32 application and the needles with 4 and 8 mm lengths are investigated in the intervention and control groups for insulin injection and the position change in response to pain level, leakage after injection and the blood sugar of diabetes type II patients.
Main outcome variables
The variations of the main consequence include: the pain, leakage after injection and blood sugar of the patient.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180213038720N1
Registration date: 2018-09-03, 1397/06/12
Registration timing: registered_while_recruiting

Last update: 2018-09-03, 1397/06/12
Update count: 0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Mostafa Soodmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5697 3303
Email address
msudmand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2018-09-04, 1397/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 32-Gauge with 4-mm Pen Needle and 8-mm Pen Needle efficiency on Glycemic Control, leakage, and pain in Type 2 diabetes Patients Referred to Razi Therapeutic and Educational Hospital, Rasht-2017
Public title
Comparison of 32-Gauge with 4-mm Pen Needle and 8-mm Pen Needle efficiency on Glycemic Control, leakage, and pain in Type 2 Diabetes Patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patient must be between 18 to 75 years old patient must have type 2 diabetes patient must have used injecting insulin at least for 2 years patient BMI must be over 18/5 Patient should not be mentally retired or have any psychological disease patient must use insulin pen
Exclusion criteria:
Patient does not want to participate in the study. Patient has skin problems in the injection site. patient does not have diabetes.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 207
Randomization (investigator's opinion)
Randomized
Randomization description
This is a cross-sectional randomized clinical trial study. The study population was type 2 diabetic patients referring to the Razi Educational Center Endocrine Center of Rasht. The method is easy to select and is randomly assigned to two groups according to the random allocation rule.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Research and technology of Guilan University of Medical Sciences, Old Building, School of Health, In Front of the 17th Shahrivar Hospital, Shahid Siadati St, Namjoo Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41469-39841
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.GUMS.REC.1396.457

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Comparison of 2 Pen Needles efficiency on patient Glycemic Control
Timepoint
Comparison of 2 Pen Needle gauges efficiency on patient Glycemic Control that patient blood sugar will be distinct in first ,third and 6th day
Method of measurement
patient blood sugar will be distinct by blood sampling and laboratory instruments.

2

Description
Comparison of 2 pen needle Gauges efficiency on needle leakage
Timepoint
Comparison of 2 Pen Needle gauges efficiency on needle leakage that will be evaliated in first ,third and 6th day
Method of measurement
leakage will be approved by the researcher

3

Description
Comparison of 2 Pen Needles efficiency on patient pain while injection
Timepoint
Comparison of 2 Pen Needle gauges efficiency on needle pain that will be evaliated in first ,third and 6th day
Method of measurement
pain will be evaluated by the Visual Analogue Scale

Secondary outcomes

1

Description
None
Timepoint
None
Method of measurement
None

Intervention groups

1

Description
Considering the crossover nature of this clinical trial in the first intervention group (A): At first, during 3 days of first hospitalization week, the insulin injection is done by the researcher with 90 degree angle and by means of Gauge 32 needle with 4 mm length and at second intervention group (B): During the last 3 days of the first week of hospitalization, insulin injection with 90 degree angle and by means of Gauge 32 needle with 8 mm length is done by the researcher. Then for post cycle therapy for both groups, there is no intervention for one day and instead the routine treatment is followed. Then the groups are substituted with each other and in the second intervention (B): In 3 last days of first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 with 4 mm length is done by the researcher and in the first intervention group (A): In 3 last days of the first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 needle and 8 mm length is done by the researcher.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Therapeutic and Educational Center
Full name of responsible person
Hossein Rafiei
Street address
Razi Therapeutic and Educational Center, Sardar jangal Street, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3354 1001
Fax
+98 13 3355 9787
Email
razi.hospital@yahoo.com
Web page address
http://www.gums.ac.ir/razi

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Shademan Nemati
Street address
Research and technology of Guilan University of Medical Sciences, Old Building, School of Health, In Front of the 17th Shahrivar Hospital, Shahid Siadati St, Namjoo Ave, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
ندارد
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Student Research Committee
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Hossein Rafiei
Position
Bachelor of science student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Ashkan Aparteman, Molaii Ave, Shohada Blvd, Rasht
City
Rasht
Province
Guilan
Postal code
4176763977
Phone
+98 13 3382 0978
Email
hrk.vairon@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mostafa Soodmand
Position
MSc Student Medical-Surgical of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Student Street, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
msudmand@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hossein Rafiei
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Ashkan Apartment, Molaii Ave, Shohada Blvd, Rasht
City
Rasht
Province
Guilan
Postal code
4176763977
Phone
+98 937 200 4177
Email
hrk.vairon@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Collected data will be given to the individuals or organizations -a raw information- that will be provided with the consent of the participants without any name, address or telephone number, and other items
When the data will become available and for how long
after we have finished the study if data crashed or disposed it will be reachable in a raw information
To whom data/document is available
just those have a Written request from authoritative research organizations
Under which criteria data/document could be used
if there was need to be called in analysis field you can call 09116470641
From where data/document is obtainable
mostafa sodmand phone number: 09116470641
What processes are involved for a request to access data/document
after confirmation the requeste, only raw and unidentifiable information from the mail will be delivered within one week.
Comments
if you have any question about this study call these numbers 09116470641 09155328439 09113312939
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