Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women With Pregnancies Complicated by Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Overall Acceptability of Remote Glucose Monitoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Overall Acceptability of Remote Glucose Monitoring
时间窗: 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.
Overall Feasibility of Remote Glucose Monitoring
时间窗: 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.
次要结局
- Changes in patient-physician communication(Change in baseline Assessment of Care for Chronic Conditions+ (ACC+) score at two weeks postpartum)
- Changes in self-efficacy(Change in baseline self-efficacy score at two weeks postpartum)