Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

Gestational Diabetes Clinical Trial

— SUGAR  

Official title:

Utilizing mHealth to Improve Diabetes in an Obstetric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504592
• Other study ID #: RSRB00068149
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregestational Diabetes

Intervention

Behavioral:
• Completion of Glucose logs
Glucose logs will be assessed by provider for completeness and accuracy

Locations

Country	Name	City	State
United States	UR Medicine Obstetrics and Gynecology	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness and accuracy of blood glucose record	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.	Every 2 weeks through study completion, up to 42 weeks
Secondary	Patient Satisfaction	Responses to patient satisfaction survey	Once prior to exiting the study, an average of 42 weeks
Secondary	Glucose values at goal	% of glucose values at goal during the study period	Every 2 weeks through study completion, up to 42 weeks
Secondary	% Change in Hemoglobin A1C	% of change in values of HbA1C during the study period	Once prior to exiting the study, up to 42 weeks
Secondary	Clinic visits	Number of clinic visits during the study period	through study completion, up to 42 weeks
Secondary	Unscheduled health care access episodes	Number of unanticipated or unscheduled health care visits during the study period	through study completion, up to 42 weeks