Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:November 1, 2017
End Date:April 28, 2018

Use our guide to learn which trials are right for you!

Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs of Women With Gestational Diabetes

Gestational diabetes mellitus (GDM) can cause adverse outcomes for the mother and fetus due
to hyperglycemia. The purpose of this study is to evaluate the feasibility of improving
pregnant women's glucose logs using a Bluetooth enabled glucose monitor and associated mobile
health application and to assess their satisfaction with using mobile health technology.

Study Question: Does use of a Bluetooth enabled serum glucose monitor in conjunction with a
mobile health application improve pregnant women's glucose log completion? This pilot study
proposes that the use of Bluetooth glucometers and mobile health applications will be
feasible and well accepted by the target population.

Methods: This project utilizes a quasi-experimental pre-post design with up to 25
participants. Over the course of eight weeks, participants will collect serum glucose logs
(SGL) for four weeks using usual care followed by SGLs for four weeks using Bluetooth-enabled
glucometers and the iGluco application. Measures will include a demographic sheet and
completed SGL. Descriptive statistics of the appropriate level will be used to summarize the
data collected. Glucose log completeness will be calculated using the total number of entries
required for the period between visits divided by the number of actual entries. For example,
if the participant has had 14 days between appointments, 56 entries would be expected, if the
patient only records 40 results the completeness score would be 0.71. Raw data will be
reported in the final manuscript under results. The data anticipated from this study include
the number of women who consented to participate, average education level, primary languages,
age range with mean age, the number of women on medication or diet only control, average
completion score for usual care phase, and average completion score for the intervention
phase. Data will also be generated and reported for the number of patients that did not bring
their logs but brought their smartphones or glucometer for transcription and the number of
patients that dropped out of the study before completion of eight weeks of glucose logs, and
a mean satisfaction score calculated. Eligibility for this study includes women who are at
least 18 years old, competent for consent, have gestational diabetes, speak English, have
ownership of a smartphone capable of running the mobile health application and are willing to
download the application.

Implications: This study has the potential to demonstrate the feasibility of improved
Self-management of GDM and provide the groundwork for future studies. The use of Bluetooth
enabled glucose monitors with mobile health applications to aid in efficient and complete
SMBG management may translate to a decrease in adverse outcomes.

Inclusion Criteria:

At least 18 years old

- Willing and able to give informed consent

- Diagnosis of gestational diabetes

- Speak English and/or Spanish

- Have ownership of a smartphone capable of running the mobile health application

- Willing to download the iGluco mobile phone application

Exclusion Criteria:

- Have knowledge that their delivery will occur prior to completion of the required
eight weeks of glucose logs

- Possess a Bluetooth enabled glucometer
We found this trial at
1
site
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials