Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women

April 9, 2024 updated by: University of Arkansas

Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women With Pregnancies Complicated by Diabetes

The overall objective is to test the feasibility and acceptability of a remote glucose monitoring program among Marshallese women with PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus) and with limited English proficiency.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

iGlucose Remote Monitoring System. iGlucose is a remote patient monitoring system. The iGlucose monitor works by analyzing a small amount of blood placed on a strip that is inserted into the monitor, similar to a standard glucometer. The iGlucose monitor will show the patient their glucose reading and will automatically send the patient's glucose reading to a database via cellular networks when the patient removes the strip from the device. The iGlucose monitor does not require any recording on the part of the patient. The iGlucose data is managed through a HIPAA-compliant Amazon Web Services (AWS) database maintained by Smartmeter. The data is available to the provider to monitor the patient's blood glucose levels accurately and in a timely manner, allowing for treatment to be adjusted. The data is available for the physician during every patient contact for review and discussion.

Patients will be provided with the iGlucose monitor at the baseline data collection. A trained bilingual research assistant will review the iGlucose guide with the participant, provide training on the use of the monitor, taking a blood glucose reading with the monitor, and the patient will use the iGlucose monitor once in front of the research assistant. The patient will receive a packet of information in their language of choice (English and/or Marshallese). The packet will include information on how to use the monitor (including the iGlucose Guide) and contact information if there are any problems with the monitor during the study. The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose. The patient will return the equipment at the completion of the study.

The participant will provide their physician's information as part of the study, so that the investigators may provide access to the iGlucose blood glucose readings through the electronic guidebook and contact the physician post-intervention to complete a survey.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Twenty Marshallese women with pregestational or gestational diabetes.

Description

Inclusion Criteria:

  • Women who self-identify as Marshallese
  • 18 years of age or older
  • ≤30 weeks pregnant
  • Receive prenatal care at University of Arkansas for Medical Sciences (UAMS) and partner clinics and hospitals
  • Have used a paper log for at least two weeks
  • Have a diagnosis of PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus).

Exclusion Criteria:

  • Women who are unable to use a glucometer by themselves
  • Have not used a paper log
  • Have a continuous glucose monitor
  • More than 30 weeks pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iGlucose Remote Glucose Monitoring
Patients will be provided with the iGlucose monitor at baseline data collection.
Device: iGlucose
The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Acceptability of Remote Glucose Monitoring
Time Frame: Change in baseline glucose monitoring satisfaction score at two weeks postpartum
The investigator will conduct a t-test (α=.05) using the post-intervention scores on the glucose monitoring satisfaction survey given to participants; a higher mean score demonstrating more satisfaction with the iGlucose remote monitoring system (range 0-60). The semi-structured interview qualitative data will be analyzed to explore the feasibility and acceptability of the intervention qualitatively. The investigator will use descriptive statistics to assess physician satisfaction with the iGlucose remote monitoring system. Given the small size of the pilot study, the investigator will conduct a review of the disaggregated data to determine the individual differences between pre- and post-intervention scores on the glucose monitoring satisfaction measure to better understand the changes in glucose monitoring satisfaction.
Change in baseline glucose monitoring satisfaction score at two weeks postpartum
Overall Feasibility of Remote Glucose Monitoring
Time Frame: Retention at two weeks postpartum
The investigator will use summary statistics to document and compare actual recruitment and retention rates with the target rates. A recruitment rate of ≥70% of all eligible participants, a retention rate through postnatal data collection of ≥80%, and an engagement rate of ≥75% of recommended daily glucose checks completed during the enrollment period will indicate feasibility.
Retention at two weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient-physician communication
Time Frame: Change in baseline Assessment of Care for Chronic Conditions+ (ACC+) score at two weeks postpartum
The investigator will conduct repeated measures t-test (α=.05) using pre- and post-intervention patient satisfaction with patient-physician communication scores from the Assessment of Care for Chronic Conditions+ (ACC+) survey measures. The repeated measures t-test will assess whether the post-intervention mean ACC+ score (range 0-100) is significantly higher than the pre-intervention score, indicating increased patient satisfaction with patient-physician communication.
Change in baseline Assessment of Care for Chronic Conditions+ (ACC+) score at two weeks postpartum
Changes in self-efficacy
Time Frame: Change in baseline self-efficacy score at two weeks postpartum
The investigator will conduct repeated measures t-test (α=.05) using pre- and post-intervention self-efficacy scores from the Diabetes Management Self-Efficacy Scale (DMSES) (range 0-80).
Change in baseline self-efficacy score at two weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Jennifer A Andersen, PhD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274147
  • UL1TR003107 (U.S. NIH Grant/Contract)
  • KL2TR003108 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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