We investigate the effect of carbohydrate counting by mobile based bolus calculator on glycemic control in adult diabetic patients. Inclusion criteria included patients with more than one year of type one or two diabetes duration who receive treatment with multiple daily injections technique, with long- and rapid-acting insulin analog and exclusion criteria included gastroparesis or celiac disease, using of or former training in carbohydrate counting and problem with using of mobile programs. The 60 Subjects were chosen from diabetic patients who referred to the endocrinology clinic of Noor Hospital (Isfahan, Iran) on year 2013-2014. After screening the subjects were divided into two groups of carbohydrate counting with mobile based bolus calculator or treatment as usual with multiple daily injections method, with simple randomization. The study was performed in a 12 weeks period. Patients in the control arm used multiple daily injections technique as usual by estimating the premeal insulin doses and using correction boluses empirically. In the carbohydrate counting arm, patients used an application which was installed on their mobile phone for measuring the needed insulin dose for each meal. The mean blood glucose level and mean HbA1c were assessed before and just after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502011181N2
Registration date:2015-02-06, 1393/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-06, 1393/11/17
Registrant information
Name
Mansour Siavash
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 0998
Email address
siavash@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-01-02, 1392/10/12
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mobile Based Bolus Calculator and Multiple Daily Injections Method for Glycemic Control in Diabetic Patients
Public title
Mobile Based Bolus Calculator for Diabetes Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-65 years aged; more than one year of type one or two diabetes duration; treatment with multiple daily injections technique, with long- and rapid-acting insulin analog. Exclusion criteria: any serious medical condition that may interfere with safe study participation; current lactation, pregnancy or inadequate contraception; gastroparesis or celiac disease; using of or former training in carbohydrate counting; problem with using of mobile programs.
Age
From 16 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences
Street address
Hezar jerib Street
City
Isfahan
Postal code
Approval date
2013-10-15, 1392/07/23
Ethics committee reference number
392512
Health conditions studied
1
Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Mean blood glucose
Timepoint
At screening and and after 12 weeks
Method of measurement
Labratory data
2
Description
Mean HbA1c
Timepoint
At screening and and after 12 weeks
Method of measurement
Labratory data
Secondary outcomes
1
Description
Hypoglycemia
Timepoint
Daily up to 12 weeks
Method of measurement
Laboratory Data
Intervention groups
1
Description
Intervention group: Patients used multiple daily injections technique with aid of an application which was installed on their mobile phone or tablet for measuring the needed insulin dose for each meal.
Category
Treatment - Drugs
2
Description
Control group: Patients used multiple daily injections technique as usual by estimating the premeal insulin doses and using correction boluses empirically.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology clinic of Noor Hospital
Full name of responsible person
Mohsen Taherian
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Hezar Jerib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
Endocrinologist
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+98 31 3668 8138
Fax
Email
siavash@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
Associate Professor
Other areas of specialty/work
Street address
Hezar jerib Street
City
Isfahan
Postal code
Phone
+98 31 3668 8138
Fax
Email
siavash@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
Endocrinologist
Other areas of specialty/work
Street address
Hezar jerib street
City
Isfahan
Postal code
Phone
+98 31 3668 8138
Fax
Email
siavash@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)