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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glooko App | Experimental | Glooko application and meter compatibility device (if required) |
|
| Traditional Care | Active Comparator | Traditional clinic reporting system: paper/MyChart/emailed glucose logs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Completion of Glucose logs | Behavioral | Glucose logs will be assessed by provider for completeness and accuracy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients must be pregnant to be enrolled in this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UR Medicine Obstetrics and Gynecology | Rochester | New York | 14620 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |