Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs
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|ClinicalTrials.gov Identifier: NCT03340311|
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus||Device: iHealth Wireless Smart Gluco- Monitoring System (BG5)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Quasi-experimental pre-post design|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs of Women With Gestational Diabetes|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||April 28, 2018|
|Actual Study Completion Date :||April 28, 2018|
(Phase one): Each participant will receive usual care (four weeks). Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded.
(Phase two): Each participant will receive a BG5 wireless glucose meter with supplies enough for four weeks. Each participant will download the iGluco application to their smartphone. Education will be given on the monitor and iGluco application use. Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded.
At the conclusion of phase 2, the participants will be asked to complete a satisfaction survey about the care received and their preference of monitors.
Device: iHealth Wireless Smart Gluco- Monitoring System (BG5)
Over the course of 8 weeks, participants collected serum glucose logs (SGL) for 4 weeks using usual care followed by SGL's log for 4 weeks using Bluetooth-enabled glucometers and the iGluco application.
- Glucose log completeness [ Time Frame: 8 weeks ]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.
- Patient satisfaction [ Time Frame: 1 day at the end of the study. ]Adapted from the PSQ-18 with a question added to determine patients device preference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340311
|United States, Virginia|
|University of Virginia Maternal Fetal Medicine Clinic|
|Charlottesville, Virginia, United States, 22901|
|Study Chair:||Emily Drake, RN, Ph.D||University of Virginia|