Comparative investigation of pregnancy outcomes among mothers with gestational diabetes using mobile application-assisted remote patient monitoring for blood glucose and mothers receiving conventional care
Comparative investigation of pregnancy outcomes among mothers with gestational diabetes who have been referred to Taleghani hospital, Tehran in the year 2021 using mobile application-assisted remote patient monitoring for blood glucose and mothers receiving conventional care
Design
This study consists of two parallel intervention and control groups without blinding. 75 participants will be recruited through a simple randomization method. 75 participants will be divided into two sets of 25 and 50 people. After that, in excel, 25 'A's and 50 'B's will be written under each other. In the adjacent column, 75 random numbers will be generated using the RAND function. Finally, by sorting both columns by randomly generated numbers, the application of A (Intervention) and B (Control) for each patient will be determined based on her turn of referral.
Settings and conduct
Mothers with GDM who were referred to the Taleghani Hospital will be categorized into intervention and control groups. The remote patient monitoring application will be installed and mothers will have to insert their measured blood glucose at the determined intervals. The variables of the study will be compared between these mothers and the control group.
Participants/Inclusion and exclusion criteria
Inclusion:
Pregnancy
Age between 18 to 40 years old
Singleton pregnancy
Diagnosis of gestational diabetes mellitus by pregnancy screening tests
Referral to the Taleghani Hospital, Tehran to receive pregnancy care
Possessing a smartphone or tablet at home
Ability to use smartphone applications
Exclusion:
Presence of any other underlying disease
Intervention groups
Intervention group: Installing the application and continuous data record
Control group: conventional care
Main outcome variables
Mother or neonate hypoglycemia, out of control BS, insulin or hospitalization, Apgar, preterm,macrosome, and small/large for gestational age birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033984N2
Registration date:2021-09-04, 1400/06/13
Registration timing:registered_while_recruiting
Last update:2021-09-04, 1400/06/13
Update count:0
Registration date
2021-09-04, 1400/06/13
Registrant information
Name
Mohsen Abbasi-Kangevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2201 8583
Email address
mohsen.abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-31, 1400/06/09
Expected recruitment end date
2022-05-30, 1401/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation of pregnancy outcomes among mothers with gestational diabetes using mobile application-assisted remote patient monitoring for blood glucose and mothers receiving conventional care
Public title
Investigation of pregnancy outcomes among mothers with gestational diabetes using mobile application-assisted remote patient monitoring
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
Age between 18 to 40 years old
Singleton pregnancy
Diagnosis of gestational diabetes mellitus (GDM) by pregnancy screening tests
Referral to the Taleghani Hosbital, Tehran, to receive pregnancy care
Possessing smart phone or tablet at home
Being able to use smart phone applications
Exclusion criteria:
Presence of any other underlying disease including cardiopulmonary disease
Presence of pregnancy complications including placenta previa or pre-eclampsia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be applied using the simple method. Indeed, 75 participants will be divided into two sets of 25 and 50 people. After that, in excel, 25 'A's and 50 'B's will be written under each other. In the adjacent column, 75 random numbers will be generated using the RAND function. Finally, by sorting both columns by randomly generated numbers, the application of A (Intervention) and B (Control) for each patient will be determined based on her turn of referral.
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
Ethics Committee School of Medicine Shahid Beheshti University of Medical Sciences
In case of insulin administration four times per day, otherwise, once per day
Method of measurement
Patient files or data extracted from the application database
2
Description
Occurrence of hypoglycemia in neonate
Timepoint
Once daily
Method of measurement
Patient files or data extracted from the application database
3
Description
number of measured out of control blood sugar
Timepoint
In case of insulin administration four times per day, otherwise, once per day
Method of measurement
In case of insulin administration four times per day, otherwise, once per day
4
Description
Insulin administration requirement
Timepoint
per visit with the physician
Method of measurement
Patient files
5
Description
Number of hospitalizations for controlling blood sugar
Timepoint
Per incidence during the study
Method of measurement
پرونده بیمار
6
Description
First minute Apgar score under seven
Timepoint
During delivery
Method of measurement
Patient files
7
Description
Fifth minute Apgar score under seven
Timepoint
During delivery
Method of measurement
Patient files
8
Description
Preterm birth
Timepoint
After birth
Method of measurement
Patient files
9
Description
Macrosomia in new born
Timepoint
After birth
Method of measurement
Patient files
10
Description
Small/large for gestational age
Timepoint
After birth
Method of measurement
Patient files
Secondary outcomes
1
Description
Mother satisfaction with the application
Timepoint
After termination of pregnancy
Method of measurement
Questionnaire
2
Description
Physician and medical staff satisfaction with the application
Timepoint
After the termination of study
Method of measurement
Questionnaire
3
Description
Patient anxiety
Timepoint
After the termination of study
Method of measurement
PAID-5 Questionnaire
Intervention groups
1
Description
Intervention group: blood sugar measuring device will be provided to this group members and the pertinent mobile application will be installed for them. Mothers under the attendance of the specialist will have to measure their blood sugar on a daily basis and record them. Moreover, the application will do the initial analysis of the data and will warn the patient, her doctor, and her trusted person when needed.
Category
Early detection
2
Description
Control group: they will receive conventional GDM care.