Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

Not Applicable

Completed

• Conditions: Gestational Diabetes; Pregestational Diabetes
• Interventions: Behavioral: Completion of Glucose logs

• Registration Number: NCT03504592
• Lead Sponsor: University of Rochester

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 Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-20
• Study Start: 2018-05-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.

Exclusion Criteria

• Not English speaking, does not have smartphone, unable to consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glooko App	Completion of Glucose logs	Glooko application and meter compatibility device (if required)
Traditional Care	Completion of Glucose logs	Traditional clinic reporting system: paper/MyChart/emailed glucose logs

Primary Outcome Measures

Name	Time	Method
Completeness and accuracy of blood glucose record	Every 2 weeks through study completion, up to 42 weeks	The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.

Secondary Outcome Measures

Name	Time	Method
% Change in Hemoglobin A1C	Once prior to exiting the study, up to 42 weeks	% of change in values of HbA1C during the study period
Clinic visits	through study completion, up to 42 weeks	Number of clinic visits during the study period
Patient Satisfaction	Once prior to exiting the study, an average of 42 weeks	Responses to patient satisfaction survey
Glucose values at goal	Every 2 weeks through study completion, up to 42 weeks	% of glucose values at goal during the study period
Unscheduled health care access episodes	through study completion, up to 42 weeks	Number of unanticipated or unscheduled health care visits during the study period

Trial Locations

Locations (1)

UR Medicine Obstetrics and Gynecology; 🇺🇸 Rochester, New York, United States