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

NCT03340311 | Completed FDA Device

• 1 other identifier: 20100
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus

Keywords

M-Health, GDM, Bluetooth, SMBG

Outcome Measures

Primary Outcomes (1)

• Glucose log completeness

  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.

  8 weeks

Secondary Outcomes (1)

• Patient satisfaction

  1 day at the end of the study.

Study Arms (1)

Pre-Post

OTHER

(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)

Interventions

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.

Pre-Post

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have knowledge that their delivery will occur prior to completion of the required eight weeks of glucose logs
• Possess a Bluetooth enabled glucometer

Sponsors & Collaborators

• Leslie Balcazar De Martinez: lead

Study Sites (1)

University of Virginia Maternal Fetal Medicine Clinic

Charlottesville, Virginia, 22901, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Emily Drake, RN, Ph.D

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctorate of Nursing Practice Student

Model Details: Quasi-experimental pre-post design

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 13, 2017
• Study Start: November 1, 2017
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)