- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02960295
The Virtual Visit for Women With Gestational Diabetes
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Pasadena, California, Estados Unidos, 91101
- Kaiser Permanente Southern California
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of gestational diabetes
- Singleton pregnancy
- <32 weeks gestation
- Age 18-45 years
- Fluent and literate in English or Spanish
- Have a cellphone with capability of internet access.
Exclusion Criteria:
- Multiple gestations (twins or higher)
- Have a history of fetal demise
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Virtual visit
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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.
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.
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.
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.
Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Compliance With Requirements for Frequency of Glucose Measures
Prazo: 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.
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1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Compliance With Self-weighing Requirements
Prazo: 1 year
|
Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100
|
1 year
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Compliance With Blood Pressure Checking Requirements
Prazo: 1 year
|
Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
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1 year
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Glucose Concentrations
Prazo: 1 year
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Mean of all glucose measures during study, in mg/dl
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1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David A Sacks, MD, Kaiser Permanente
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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. Erratum In: Diabetes Care. 2019 Apr;42(4):701.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10539 (DAIDS ES Registry Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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