Comparison effectiveness of educational insulin injection with or without telephone followup , on the amount of glycosylated hemoglobin in type 2 diabetic patients attending Gorgan 5 Azar hospital diabetes clinics in years 2014
The purpose of this study was to investigate the effect of standard insulin injections and telephone follow-up on daily variations in blood sugar and insulin levels of glycosylated hemoglobin compared with no standard of education. This study was a randomized clinical trial with a sample size of 64 diabetic patients referred to 5th Azar Hospital Diabetes Clinic. The intervention group consisted of 32 patients who inject insulin in addition to the standard training for 3 months being followed up with a phone call. Follow-up 2 times a week during the first month and once a week during the second and third month is done. The control group consisted of 32 diabetic patients referred to diabetes clinic of 5th Azar hospital; insulin injections will be used only standard training. For the patients at zero, three months after the intervention glycosylated hemoglobin levels is measured. Blood sugar levels on a daily basis and will be evaluated using the devices. Data is collected and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404185866N17
Registration date:2014-10-10, 1393/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of educational insulin injection with or without telephone followup , on the amount of glycosylated hemoglobin in type 2 diabetic patients attending Gorgan 5 Azar hospital diabetes clinics in years 2014
Public title
Training and pursuit of insulin on glycosylated hemoglobin in diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : having the ability to read and write; residence in Gorgan city and access to a cell phone or landline; ability to use mobile and sms; not having speech and hearing and vision problems; aged 10 to 6 to 50 years old; diabetic patients require insulin; risk of type 2 diabetes; undergoing insulin therapy during the last 6 months; lack advanced form of the known mental diseases and disorders of vital organs. Exclusion criteria: hospital admissions due to illness during the study period; changes in diabetes medications to oral glucose -lowering drugs; catching osmolar hyperglycemic ketoacidosis syndrome; lack of desire to continue the legal guardian of the patient's; deceased patient.
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences Ethics Committee
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
4934174515
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
13930228436
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
Admission and 3 months later
Method of measurement
Lab test
2
Description
Blood sugar.
Timepoint
Daily for 3 months
Method of measurement
Lab test
Secondary outcomes
1
Description
Self-injection of insulin
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Self-injection of insulin Questionnaire
Intervention groups
1
Description
The intervention group included 32 diabetic patients treated with insulin, which are trained by standard injection of insulin. The glycated hemoglobin checked, self-injection of insulin questionnaire must complete . Daily for three months thay record their blood glucose levels by glucometer and chart in a booklet. after three months, self-care questionnair and HbA1C are re-checked. Within 3 months by telephone follow up during the first month 2 times a week and the second and third month follow-up is done once a week.
Category
Prevention
2
Description
The control group included 32 diabetic patients treated with insulin, which are trained by standard injection of insulin. The glycated hemoglobin checked, self-injection of insulin questionnaire must complete . Daily for three months and record their blood glucose levels by glucometer andchart ina booklet. after three months, self-care questionnair and HbA1C are re-checked.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5 Azar hospital
Full name of responsible person
Asrin Safari
Street address
5 Azar hospital, Gorgan, Golestan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science, Research & Technology
Full name of responsible person
Dr. Masoud Khoshnia
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science, Research & Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Asrin Safari
Position
Graduate student in nursing care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
asrin_safari@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
sanagoo@goums.ac.ir; a_sanagu@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
sanagoo@goums.ac.ira_sanagu@yahoo.com
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)