Diabetes, Gestational
Conditions
Brief summary
This is a feasibility study of care for women with gestational diabetes (GDM) using electronic equipment to participate in virtual office visits. Participants will be trained in the use of glucose meters, scales, and sphygmomanometers which are Bluetooth connected to an app on their cellphones. Fetal well-being will be assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and telephone visits.
Detailed description
The core elements of a prenatal visit for any pregnant woman include assessment of BP, weight, and presence of fetal heart activity. The treatment of GDM additionally requires the measurement of and review of maternal glycemia. Technology exists for patients to measure these parameters and to relay this information securely directly from these devices via the internet to the healthcare provider's office. A key element of antepartum care for GDM, self-monitoring of blood glucose (SMBG), has for some years been conducted with memory-based portable glucose meters. To assure accuracy in reports of patient measurements, it is important that all devices be of a design wherein results of measures of patient parameters are transmitted in unedited fashion directly devices to the health care provider. While no data exists about the accuracy of self-reporting of patient weight and blood pressure, intentional or unintentional alteration in reports of self-monitored glucose results is a known risk of reliance on patient self-reported data. This pilot study will explore the feasibility of the use of this technology from patients' homes in lieu of an office visit.
Interventions
DEVICE1-Self-monitoring of blood glucose
Self-monitoring of blood glucose 4 times daily: fasting and 1-hour after each meal. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Intervention: At every office visit and at every telephone (virtual) visit the patient's physician will review glucose results and make adjustments in diet, activity, or medication to bring glucose into desired range.
DEVICE2-Self-weighing
Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Consultation with the nutritionist will be obtained for women gaining in excess of or less than that indicated for her pre-pregnancy BMI, per Institute of Medicine (IOM) standards.
DEVICE3-Self-checking of blood pressure
Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Patients with elevated blood pressure will be requested to come to Obstetrics Triage immediately for further assessment.
DEVICE4-Checking fetal heart rate
Patient will record her fetus' heart rate with a Doppler device at least once weekly. The patient will immediately report to Labor and Delivery for any fetal heart rate below 100 beats per minute or greater than 160 beats per minute over a 10 minute observation period.Those reporting a fetal heart rate outside of the normal range will be requested to come to ObstetricTriage for further assessment.
PROCEDURE5-Visits with caregivers
Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.
Sponsors
Kaiser Permanente
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of gestational diabetes 2. Singleton pregnancy 3. \<32 weeks gestation 4. Age 18-45 years 5. Fluent and literate in English or Spanish 6. Have a cellphone with capability of internet access.
Exclusion criteria
1. Multiple gestations (twins or higher) 2. Have a history of fetal demise 3. Have a history of chronic health problems that might affect outcomes (such as HIV, treatment with steroids, significant cardiac or renal disease, or chronic hypertension), and those who had bariatric surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Requirements for Frequency of Glucose Measures | 1 year | Each patient is requested to check her blood glucose four times a day: fasting and one hour after the first bite of each meal. Compliance with this requirement will be measured for each patient by dividing the number of daily glucose checks actually performed by the number of days in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Self-weighing Requirements | 1 year | Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100 |
| Compliance With Blood Pressure Checking Requirements | 1 year | Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100 |
| Glucose Concentrations | 1 year | Mean of all glucose measures during study, in mg/dl |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Visit Pregnant women with GDM who will:
1-self-monitor blood glucose four times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers
1. Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.
2. Self-weighing: Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.
3. Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.
4. Checking fetal | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Virtual Visit |
|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 1.7 |
| Compliance with requirements of study | 10 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Compliance With Requirements for Frequency of Glucose Measures
Each patient is requested to check her blood glucose four times a day: fasting and one hour after the first bite of each meal. Compliance with this requirement will be measured for each patient by dividing the number of daily glucose checks actually performed by the number of days in the study.
Time frame: 1 year
Population: women with gestational diabetes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Visit | Compliance With Requirements for Frequency of Glucose Measures | 3.1 number of glucose checks per pt per day | Standard Deviation 1.26 |
Comparison: In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.
Secondary
Compliance With Blood Pressure Checking Requirements
Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
Time frame: 1 year
Population: Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Visit | Compliance With Blood Pressure Checking Requirements | 162.5 percentage of Blood Pressure checks | Standard Deviation 69.48 |
Secondary
Compliance With Self-weighing Requirements
Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100
Time frame: 1 year
Population: Women with gestational diabetes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Visit | Compliance With Self-weighing Requirements | 136 percentage of weekly weights performed | Standard Deviation 76 |
p-value: <0.05Pearson correlation (r)
p-value: <0.05Pearson correlation coefficient (r)
p-value: <0.05Pearson correlation coefficient (r)
Secondary
Glucose Concentrations
Mean of all glucose measures during study, in mg/dl
Time frame: 1 year
Population: Mean of all glucose measures during study, in mg/dl
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Visit | Glucose Concentrations | 106.0 milligrams per deciliter | Standard Deviation 3.83 |