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

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iHealth Wireless Smart Gluco- Monitoring System (BG5)
Sponsored by
Leslie Balcazar De Martinez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes Mellitus focused on measuring M-Health, GDM, Bluetooth, SMBG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia Maternal Fetal Medicine Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pre-Post

Arm Description

(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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient satisfaction
Adapted from the PSQ-18 with a question added to determine patients device preference.

Full Information

First Posted
October 20, 2017
Last Updated
April 30, 2018
Sponsor
Leslie Balcazar De Martinez
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1. Study Identification

Unique Protocol Identification Number
NCT03340311
Brief Title
Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs
Official Title
Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs of Women With Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
April 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leslie Balcazar De Martinez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
M-Health, GDM, Bluetooth, SMBG

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasi-experimental pre-post design
Masking
None (Open Label)
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Post
Arm Type
Other
Arm Description
(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.
Intervention Type
Device
Intervention Name(s)
iHealth Wireless Smart Gluco- Monitoring System (BG5)
Intervention Description
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 Outcome Measure Information:
Title
Glucose log completeness
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Adapted from the PSQ-18 with a question added to determine patients device preference.
Time Frame
1 day at the end of the study.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Drake, RN, Ph.D
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Virginia Maternal Fetal Medicine Clinic
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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