Gestational Diabetes, Pregestational Diabetes
Conditions
Brief 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.
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.
Interventions
BEHAVIORALCompletion of Glucose logs
Glucose logs will be assessed by provider for completeness and accuracy
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness and accuracy of blood glucose record | Every 2 weeks through study completion, up to 42 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Once prior to exiting the study, an average of 42 weeks | Responses to patient satisfaction survey |
| Glucose values at goal | Every 2 weeks through study completion, up to 42 weeks | % of glucose values at goal during the study period |
| % Change in Hemoglobin A1C | Once prior to exiting the study, up to 42 weeks | % of change in values of HbA1C during the study period |
| Clinic visits | through study completion, up to 42 weeks | Number of clinic visits during the study period |
| Unscheduled health care access episodes | through study completion, up to 42 weeks | Number of unanticipated or unscheduled health care visits during the study period |
Countries
United States
Outcome results
None listed