Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 6:00 AM
Study NCT ID:
NCT05453357
Status:
WITHDRAWN
Last Update Posted:
2024-11-12
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women with Pregnancies Complicated by Diabetes
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding ended before enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UL1TR003107 | NIH | None | https://reporter.nih.gov/quic… | View |
| KL2TR003108 | NIH | None | https://reporter.nih.gov/quic… | View |