Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT03504592
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Utilizing mHealth to Improve Diabetes in an Obstetric Population
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUGAR
Brief Summary:
This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.
Detailed Description:
This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.
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?:
None
Is an FDA AA801 Violation?: