Evaluation of a new protocol for controlling blood glucose and comparing it with old strategies for controlling blood glucose in patients who hospitalized in infectious ward
ٍEvaluation of a new protocol for controlling blood glucose in patients who hospitalized in infectious ward
Design
A non-randomized clinical trial with parallel group
Settings and conduct
Patients with diabetes who admitted to the Infectious Diseases department of Loghman Hakim Hospital, Tehran, included. After considering inclusion and not-inclusion criteria, patients divided into two groups. The first group receives short-acting insulin by sliding sacle before each meal, and in the second group, patients receive a combination of short-acting and long-acting insulin based on the needed daily insulin dose.
Participants/Inclusion and exclusion criteria
Patients over the 18 years old with diabetes who have been admitted in infectious ward due to pneumonia, cellulitis, or diabetic foot infection included. These patients were used subcutaneous insulin. Pregnant women, patients with end stage renal disease, patients who used intravenous insulin, surgical patients, and patients receiving total parental nutrition are not included.
Intervention groups
The first group treat with insulin by sliding scale and receive different doses of short acting insulin based on the level of glucose before meals.
The second group, based on the calculated daily insulin, receive certain dose of insulin which is combination of short and long-acting insulin twice a day.
Main outcome variables
Blood glucose level; Fever; Length of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130917014693N9
Registration date:2019-08-15, 1398/05/24
Registration timing:retrospective
Last update:2019-08-15, 1398/05/24
Update count:0
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2017-08-22, 1396/05/31
Trial completion date
2017-09-06, 1396/06/15
Scientific title
Evaluation of a new protocol for controlling blood glucose and comparing it with old strategies for controlling blood glucose in patients who hospitalized in infectious ward
Public title
Evaluation of a new protocol for controlling blood glucose in hospitalized patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetes mellitus
Age more than 18 years ago
Patients under subcutaneous insulin regimen
Patients who hospitalized in infectious diseases ward due to pneumonia, cellulitis, and diabetic foot infection
Exclusion criteria:
Pregnant women
Surgical patients
Patients on intravenous insulin
Patients with end stage renal disease
Patients on total parental nutrition
Patients who did not sign the patient informed consent form
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
90
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
Research Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Streptococcus pneumoniae as the cause of diseases classified elsewhere
3
Description of health condition studied
cellulitis
ICD-10 code
L03.03
ICD-10 code description
Cellulitis of toe
4
Description of health condition studied
Diabetic foot infection
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Blood glucose level
Timepoint
Every six hours
Method of measurement
Glucometer
Secondary outcomes
1
Description
Fever
Timepoint
Every six hours
Method of measurement
Mercury Therommeter
2
Description
Durration of hospitalization
Timepoint
At discharged
Method of measurement
Patient record
Intervention groups
1
Description
Intervention group: In this group the needed daily insulin calculate. This dose includes short acting insulin (Regular, Exir Company) and long action insulin (NPH, Exir Company). The patients will receive this combined dose as twice day by subcutaneous injection. This dose will be administered every morning and every evening. This protocol will be continued in all of hospitalization duration.
Category
Treatment - Drugs
2
Description
Control group: In this group, the blood glucose level of patients will be determined before each essential meals by glucometer. Then, different doses of short acting insulin (Regular, Exir Company) will be administered by subcutaneous injection. This protocol will be continued in all of hospitalization duration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman-hakim hospital
Full name of responsible person
Zahra Sahraei
Street address
Makhsoos St, South Karegar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 5102 5000
Email
zahra.sahraei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
Faculty of Pharmacy-Niyayesh intersection-Valiasr St
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
zahra.sahraei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
zahra.sahraei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e Asr Ave.,Niayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
zahra.sahraei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Saffaei
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e Asr Ave.,Niayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
alisaffaei.ss@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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Primary outcome data after making unrecognizable will be released.
When the data will become available and for how long
Six months after publishing the results primary outcome data will be released.
To whom data/document is available
Researchers after allowance of corresponding author could have the permission to have the data.
Under which criteria data/document could be used
Performing any analysis will be allowed only with the permission of corresponding author.
From where data/document is obtainable
Corresponding researcher
What processes are involved for a request to access data/document
After requesting to reach data, corresponding author will check the allowance, then the researcher will be informed about it.