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Completed

NCT Number: NCT03340311

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Maternal Fetal Medicine Clinic

Charlottesville, Virginia, 22901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iHealth Wireless Smart Gluco- Monitoring System (BG5)

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Leslie Balcazar De Martinez

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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