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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes, Gestational, Diabetes Mellitus Type 2 Pre-Existing

Intervention / Treatment
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* Device: iGlucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iGlucose Remote Glucose Monitoring<br>Patients will be provided with the iGlucose monitor at baseline data collection. | Device: iGlucose<br>* The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Acceptability of Remote Glucose Monitoring | 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 | 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 | 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 | 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 |