Smartphone Utilization for Glucose Monitoring and Antenatal Reporting (SUGAR)

Utilizing mHealth to Improve Diabetes in an Obstetric Population

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Pregestational Diabetes
• Intervention / Treatment: Behavioral: Completion of Glucose logs

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • UR Medicine Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glooko App; Glooko application and meter compatibility device (if required)	Behavioral: Completion of Glucose logs; Glucose logs will be assessed by provider for completeness and accuracy
Active Comparator: Traditional Care; Traditional clinic reporting system: paper/MyChart/emailed glucose logs	Behavioral: Completion of Glucose logs; Glucose logs will be assessed by provider for completeness and accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: RSRB00068149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No