- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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Pasadena, California, Förenta staterna, 91101
- Kaiser Permanente Southern California
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Virtual visit
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Compliance With Requirements for Frequency of Glucose Measures
Tidsram: 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.
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Compliance With Self-weighing Requirements
Tidsram: 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
|
Compliance With Blood Pressure Checking Requirements
Tidsram: 1 year
|
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
Tidsram: 1 year
|
Mean of all glucose measures during study, in mg/dl
|
1 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David A Sacks, MD, Kaiser Permanente
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10539 (DAIDS ES Registry Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på Diabetes, graviditet
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Merck KGaA, Darmstadt, GermanyMerck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, GermanyAvslutadSmall Gestational Age (SGA)
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Avslutad
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T.C. ORDU ÜNİVERSİTESİEge UniversityAvslutadGestational viktökningKalkon
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Milton S. Hershey Medical CenterIndragen
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University of HawaiiAvslutadGestational viktökningFörenta staterna
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Helena PiccininiNova Scotia Health AuthorityIndragenGestational viktökningKanada
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West China HospitalWest China Second University HospitalAvslutad
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Technical University of MadridAvslutad
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International Centre for Diarrhoeal Disease Research...Obstetrical and Gynaecological Society of Bangladesh (OGSB)Aktiv, inte rekryterande