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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual visit | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-Self-monitoring of blood glucose | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Compliance With Blood Pressure Checking Requirements |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women meeting inclusion and exclusion criteria (see below) who volunteer to participate for the study. Volunteers will be solicited sequentially.
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| Name | Affiliation | Role |
|---|---|---|
| David A Sacks, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California | Pasadena | California | 91101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26394017 | Result | Given JE, Bunting BP, O'Kane MJ, Dunne F, Coates VE. Tele-Mum: A Feasibility Study for a Randomized Controlled Trial Exploring the Potential for Telemedicine in the Diabetes Care of Those with Gestational Diabetes. Diabetes Technol Ther. 2015 Dec;17(12):880-8. doi: 10.1089/dia.2015.0147. Epub 2015 Sep 22. | |
| 22512287 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Visit | Pregnant women with gestational diabetes (GDM) who will: 1-self-monitor blood glucose 4 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
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pregnant women with gestational diabetes
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| ID | Title | Description |
|---|---|---|
| BG000 | 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
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, in years, was collected upon enrollment for the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | women with gestational diabetes | Posted | Mean | Standard Deviation | number of glucose checks per pt per day | 1 year |
|
|
1 year
Definitions used were those of clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Jacobsen MD, PhD. Director, Department of Research and Evaluation | Kaiser Permanente Southern California | 626-564-3470 | Steven.J.Jacobsen@nsmtp.kp.org |
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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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| ID | Term |
|---|---|
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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|
| 2-Self-weighing | Device | 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. |
|
| 3-Self-checking of blood pressure | Device | 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. |
|
| 4-Checking fetal heart rate | Device | 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. |
|
| 5-Visits with caregivers | Procedure | Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time. |
|
Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
| 1 year |
| Glucose Concentrations | Mean of all glucose measures during study, in mg/dl | 1 year |
| Homko CJ, Deeb LC, Rohrbacher K, Mulla W, Mastrogiannis D, Gaughan J, Santamore WP, Bove AA. Impact of a telemedicine system with automated reminders on outcomes in women with gestational diabetes mellitus. Diabetes Technol Ther. 2012 Jul;14(7):624-9. doi: 10.1089/dia.2012.0010. Epub 2012 Apr 18. |
| 28077459 | Derived | Sacks DA, Ling Grant D, Macias M, Li X, Lawrence JM. The Virtual Office Visit for Women With Gestational Diabetes Mellitus. Diabetes Care. 2017 Mar;40(3):e34-e35. doi: 10.2337/dc16-2569. Epub 2017 Jan 11. No abstract available. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sex: Female, Male | All participants were pregnant women | Count of Participants | Participants |
|
| Compliance with requirements of study | Number of participants who met all the eligibility criteria required to participate in the study | Count of Participants | Participants |
|
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|
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| 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 | Women with gestational diabetes | Posted | Mean | Standard Deviation | percentage of weekly weights performed | 1 year |
|
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|
|
| 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 | Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100 | Posted | Mean | Standard Deviation | percentage of Blood Pressure checks | 1 year |
|
|
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| Secondary | Glucose Concentrations | Mean of all glucose measures during study, in mg/dl | Mean of all glucose measures during study, in mg/dl | Posted | Mean | Standard Deviation | milligrams per deciliter | 1 year |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Other |
This is an observational study |
| Pearson correlation coefficient (r) | <0.05 | Other |