SUCCESSFUL DATA COLLECTION
TOOLS:
MONITOR GESTATIONAL DIABETES MELLITUS
PATIENT WITH SENSOR AND APP BLOOD
SUGAR MONITORING SYSTEM
INTRODUCTION
• Gestational Diabetes Mellitus (GDM) is a metabolic disorder characterized by
abnormally high blood sugars that happen for the first time during pregnancy.
• GDM affects about 14% of all pregnancies
• Possible severe consequences including heart attacks, miscarriages, and postpregnancy diabetes mellites.
• Burden of GDM on the US healthcare system is approximately $636 million
• Management with excising, diet, and blood sugar monitoring
BLOOD SUGAR MANAGEMENT: FREESTYLE LIBRE WITH APP
• Biomedical instrument for blood sugar measurement
• Continuous glucose monitor (CGM) device
• Blood Sugar Check with a painless scan; No fingerstick
• Small electrode placed under the skin
• Blood Glucose reading on set intervals or as needed
• Periodic patient monitoring necessary for proper monitoring
GESTATIONAL DM PATIENT MONITORING
• Sensor change every 14 days
• Blood sugar check on demand
• Automatic data collection
• Appointment with provider every 3 to 6 months
• Remote transmission of data to provider
• Better understanding of blood sugar variation by
the patient
Questions
Gender
QUESTIONNAIRE
Answers
□ Male
□ Female
Age
1. How often do you change the sensor implanted on your skin?
(Select only one answer)
□ Every week
□ Every 2 weeks
□ Every month
2. How often do you scan the sensor with your phone?
□ Every 4 hour
(Select only one answer)
□ Every 6 hours
□ Once a day
3. What do you do if your blood sugar is low?
□ Drink orange Juice
(Select only one answer)
□ Call 911
□ Do Nothing
4. What do you do if you feel dizzy and tired?
□ Go to sleep
(Select only one answer)
□ Check blood sugar
□ Call 911
5. How do you find out how much insulin you should give to yourself?
□ Take the same dose as usual
(Select only one answer)
□ Check the prescription
□ Call the pharmacy
6. I get upset when my blood sugar is high very often.
□ Yes
(Select only one answer)
□ No
7. I am afraid each time when my blood sugar is high.
□ Yes
(Select only one answer)
□ No
8. I think I am each time my blood sugar is high.
□ Yes
(Select only one answer)
□ No
9. There is nothing I can do to prevent my blood sugar from getting too low or □ Yes
too high. (Select only one answer)
□ No
10. I can eat what I want when I have this device on.
(Select only one answer)
11. What do you do if your device is not working?
(Select only one answer)
12. Do you have a backup glucometer?
(Select only one answer)
13. How often do you visit your primary care provider for a follow-up?
(Select only one answer)
□ Yes
□ No
□ Use a traditional glucometer
□ Call the service number
□ Do Nothing
□ Yes
□ No
□ Every 4 hour
□ Every 6 hours
□ Once a day
PHYSIOLOGICAL CONCEPTS
• Implantation of a sensor under the skin: Blood sugar measuring through a sensor
• No need to change the sensor for 14 days: Reduce risks of infections and skin
integrity issues
• Minimal invasive procedure: One small needle stick through the skin every 14 days
• Measurement of blood sugar variations and display through an app
• Changes detected and action taken for blood sugar levels corrections
PHYSIOLOGICAL CONCEPTS (2): CLASSIFICATION OF
MEASUREMENT INSTRUMENT
• In vivo continuous measurement instrument
• Minimal invasive through small intradermal needle with sensor
• External ship for data collection
• Phone scanning with data transmission to app for display
Q8 hours
Q14 Days
VS
PHYSIOLOGICAL CONCEPTS (3): CATEGORIES OF
PHYSIOLOGICAL VARIABLES AND ORGANISM-INSTRUMENT SYSTEM
• Blood glucose can be considered as body products
• The subject is undergoing a transient condition: GDM is
• Low stimulus applied to the subject
• A sensor is used to detect the blood sugar change
• Measurements are converted and stored in a chip
• Phone are used for display after scanning and data conversion
PSYCHOLOGICAL CONCEPTS
• Clinical evaluation of patients: How is the patient pathologic condition?
• Assessment of treatment response: Is patient disease controlled?
• Evaluation of compliance: Is the patient adhering to the treatment protocol?
• Identification of areas where the patient needs support: Where is change
necessary?
PSYCHOLOGICAL CONCEPTS: SELECTION OF INSTRUMENTS
• Validity: The questionnaire measure measures patients’ adherence to treatment
protocol and clinical progress
Content validity: The questionnaire is comprehensive in assessing the patient
Criterion-related validity:
o Predictive: After collecting a large number of data, the evaluation of these data
can help in making predictions
o Concurrent: Data collected are compared to traditional GDM management methods
Criterion-related validity: The questionnaire enables an adequate
follow-up of GDM patients
• Reliability:
Are data produce by the questionnaire consistent?
PSYCHOLOGICAL CONCEPTS: TYPES AND
CHARACTERISTICS OF INSTRUMENTS
• Structured interviews: Organized interviews with pre-defined questions
• Semi-structured interviews: Meeting between participants and investigators with
space provided for discussion.
• Self-reported scales: Responses directly from participants
• Open-ended questions: Lead to answers with more details
• Closed-ended questions: Lead to precise answers
REMOTE MANAGEMENT OF GDM
• Patient management in home setting
• Continuous collection of data on patient health
• Possibility of transmission of data in a health management center for
immediate action when needed
• Enhanced involvement of patients in the care process
• Possibility of horizontal deployment of lessons learned
MANAGEMENT OF DM FOR INPATIENTS
• Possibility of continuous data collection and transmission on patient’s blood
• Improved time and resource management
• Enhanced patient safety
• Reduction of adverse effects
• Improvement of the quality of care through the reemployment of resources
FUTURE PERSPECTIVES FOR HEALTHCARE
• Possibility to expand the technology to other types of lab work:
use of implants and sensors for data collection and transmission
• Systematic and continuous monitoring for patients at risk
• Data transmission and processing for decision making
• Enhanced patient safety through improved monitoring
• Decreased hospitalization through improved health conditions
REFERENCE
• DeSisto, C. L., Kim, S. Y., & Sharma, A. J. (2014). Peer Reviewed: Prevalence Estimates of Gestational Diabetes
Mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007–2010. Preventing
chronic disease, 11.
• Hod, M., Kapur, A., Sacks, D. A., Hadar, E., Agarwal, M., Di Renzo, G. C., ... & Divakar, H. (2015). Initiative on
gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care. International Journal of
Gynecology and Obstetrics, 131, S173-S211.
• Kudva, Y. C., Ahmann, A. J., Bergenstal, R. M., Gavin III, J. R., Kruger, D. F., Midyett, L. K., ... & Harris, D. R. (2018).
Approach to using trend arrows in the FreeStyle Libre flash glucose monitoring systems in adults. Journal of the
Endocrine Society, 2(12), 1320-1337.
• Li, G., Wei, T., Ni, W., Zhang, A., Zhang, J., Xing, Y., & Xing, Q. (2020). Incidence and Risk Factors of Gestational
Diabetes Mellitus: A Prospective Cohort Study in Qingdao, China. Frontiers in Endocrinology, 11.
• Milln, J. M., Walugembe, E., Ssentayi, S., Nkabura, H., Jones, A. G., & Nyirenda, M. J. (2020). Comparison of oral
glucose tolerance test and ambulatory glycaemic profiles in pregnant women in Uganda with gestational diabetes
using the FreeStyle Libre flash glucose monitoring system. BMC pregnancy and childbirth, 20(1), 1-9.
• Pramanik, P. K. D., Solanki, A., Debnath, A., Nayyar, A., El-Sappagh, S., & Kwak, K. S. (2020). Advancing Modern
Healthcare With Nanotechnology, Nanobiosensors, and Internet of Nano Things: Taxonomies, Applications,
Architecture, and Challenges. IEEE Access, 8, 65230-65266.