Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Utilizing mHealth to Improve Diabetes in an Obstetric Population

Conditions
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Gestational Diabetes, Pregestational Diabetes

Intervention / Treatment
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* Behavioral: Completion of Glucose logs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |