Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-18 @ 11:41 AM
Study NCT ID:
NCT02960295
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Virtual Visit for Women With Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Steven.J.Jacobsen@nsmtp.kp.org', 'phone': '626-564-3470', 'title': 'Steven Jacobsen MD, PhD. Director, Department of Research and Evaluation', 'organization': 'Kaiser Permanente Southern California'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Definitions used were those of clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Virtual Visit', 'description': "Pregnant women with GDM who will:\n\n1-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\n\n1. 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.\n2. Self-weighing: Self-weighing on electronic scale at least once a week.\n3. Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer.\n4. Checking fetal heart rate: Patient will record her fetus' heart rate with a Doppler device at least once weekly.\n5. Visits with caregivers: Telephone visits will alternate with in-office visits", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compliance With Requirements for Frequency of Glucose Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Visit', 'description': 'all participants'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.26', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': '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.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'There was no comparison group and no test of statistical significance.', 'otherAnalysisDescription': 'This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': '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.', 'unitOfMeasure': 'number of glucose checks per pt per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'women with gestational diabetes'}, {'type': 'SECONDARY', 'title': 'Compliance With Self-weighing Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Visit', 'description': '1-Self-monitoring of blood glucose (four times daily). 2-Self-weighing (weekly). 3-Self-checking of blood pressure (weekly). 4-Checking fetal heart rate (weekly). 5-Visits with caregivers.\n\n1. 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.\n2. 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'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '76', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Pearson correlation (r)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This is an observational study'}, {'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Pearson correlation coefficient (r)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This is an observational study'}, {'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Pearson correlation coefficient (r)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100', 'unitOfMeasure': 'percentage of weekly weights performed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with gestational diabetes'}, {'type': 'SECONDARY', 'title': 'Compliance With Blood Pressure Checking Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Visit', 'description': 'all participants'}], 'classes': [{'categories': [{'measurements': [{'value': '162.5', 'spread': '69.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100', 'unitOfMeasure': 'percentage of Blood Pressure checks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100'}, {'type': 'SECONDARY', 'title': 'Glucose Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Visit', 'description': 'all participants'}], 'classes': [{'categories': [{'measurements': [{'value': '106.0', 'spread': '3.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Mean of all glucose measures during study, in mg/dl', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean of all glucose measures during study, in mg/dl'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Virtual Visit', 'description': "Pregnant women with gestational diabetes (GDM) who will:\n\n1-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\n\n1. 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.\n2. Self-weighing: Self-weighing on electronic scale at least once a week. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.\n3. Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment.\n4. Checking fetal"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Virtual Visit', 'description': "Pregnant women with GDM who will:\n\n1-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\n\n1. 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.\n2. 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.\n3. 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.\n4. Checking fetal"}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age, in years, was collected upon enrollment for the study', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All participants were pregnant women', 'unitOfMeasure': 'Participants'}, {'title': 'Compliance with requirements of study', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who met all the eligibility criteria required to participate in the study', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Pregnant women with gestational diabetes'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2016-10-18', 'resultsFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-04', 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance With Requirements for Frequency of Glucose Measures', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Compliance With Self-weighing Requirements', 'timeFrame': '1 year', 'description': 'Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100'}, {'measure': 'Compliance With Blood Pressure Checking Requirements', 'timeFrame': '1 year', 'description': 'Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100'}, {'measure': 'Glucose Concentrations', 'timeFrame': '1 year', 'description': 'Mean of all glucose measures during study, in mg/dl'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes, Gestational']}, 'referencesModule': {'references': [{'pmid': '26394017', 'type': 'RESULT', 'citation': "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."}, {'pmid': '22512287', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28077459', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a feasibility study of care for women with gestational diabetes (GDM) using electronic equipment to participate in virtual office visits.\n\nParticipants 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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women meeting inclusion and exclusion criteria (see below) who volunteer to participate for the study. Volunteers will be solicited sequentially.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of gestational diabetes\n2. Singleton pregnancy\n3. \\<32 weeks gestation\n4. Age 18-45 years\n5. Fluent and literate in English or Spanish\n6. Have a cellphone with capability of internet access.\n\nExclusion Criteria:\n\n1. Multiple gestations (twins or higher)\n2. Have a history of fetal demise\n3. 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.'}, 'identificationModule': {'nctId': 'NCT02960295', 'briefTitle': 'The Virtual Visit for Women With Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'The Virtual Visit for Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': '10539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual visit', 'description': '1. Self-monitoring of blood glucose (four times daily).\n2. Self-weighing (weekly).\n3. Self-checking of blood pressure (weekly).\n4. Checking fetal heart rate (weekly).\n5. Visits with caregivers.', 'interventionNames': ['Device: 1-Self-monitoring of blood glucose', 'Device: 2-Self-weighing', 'Device: 3-Self-checking of blood pressure', 'Device: 4-Checking fetal heart rate', 'Procedure: 5-Visits with caregivers']}], 'interventions': [{'name': '1-Self-monitoring of blood glucose', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Virtual visit']}, {'name': '2-Self-weighing', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Virtual visit']}, {'name': '3-Self-checking of blood pressure', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Virtual visit']}, {'name': '4-Checking fetal heart rate', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Virtual visit']}, {'name': '5-Visits with caregivers', 'type': 'PROCEDURE', 'description': 'Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.', 'armGroupLabels': ['Virtual visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'David A Sacks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}