Mobile App Logging for Diabetes in Pregnancy

Study Overview
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Brief Summary
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To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.

Detailed Description
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Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics. Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.

Official Title
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Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes

Conditions
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Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: OneTouch Reveal application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Verified intrauterine pregnancy At least 12 weeks gestation Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus. Exclusion Criteria: Patients with less than 4 weeks anticipated to be remaining in pregnancy Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking Type 1 diabetes mellitus Non-English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile App arm<br>Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app | Behavioral: OneTouch Reveal application<br>* Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging<br>|
| No Intervention: Paper Log Arm<br>Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | percentage of actual blood glucose values logged compared to expected. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of in-range blood glucose levels | Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy