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

Sponsor
University of Arkansas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05453357
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH)
20
Enrollment
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iGlucose

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women With Pregnancies Complicated by Diabetes
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Overall Acceptability of Remote Glucose Monitoring [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.

  2. Overall Feasibility of Remote Glucose Monitoring [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.

Secondary Outcome Measures

  1. Changes in patient-physician communication [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.

  2. Changes in self-efficacy [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Arkansas
  • National Center for Advancing Translational Science (NCATS)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT05453357
Other Study ID Numbers:
  • 274147
  • UL1TR003107
  • KL2TR003108
First Posted:
Jul 12, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 12, 2022