Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes
Conditions
Keywords
technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy
Brief summary
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
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.
Interventions
BEHAVIORALOneTouch Reveal application
Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging
Sponsors
Carolyn Zahler-Miller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 4 weeks | percentage of actual blood glucose values logged compared to expected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of in-range blood glucose levels | 4 weeks | Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged. |
Countries
United States
Contacts
Primary ContactRebecca Keipper, MD
Backup ContactCarolyn M Zahler-Miller, MD
Outcome results
None listed