- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01818557
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes (GLIMPSE)
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. The primary goal is to establish the most cost-effective modality while still being able to detect patients who require therapy in a timely fashion. The investigators plan to evaluate this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with GDM, is every other day blood glucose testing non-inferior compared to every day blood glucose testing, as measured by the difference of less than 5% in birth weight?
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and 32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose 1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria listed below, she will be offered participation in the trial and randomized to every day blood glucose testing or every other day blood glucose testing for the remainder of her pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be provided counseling and education and will attempt adequate blood glucose control with medical nutritional therapy alone for one week. During this period, all patients will test their blood glucose values daily. Only after this week is completed will a subject be approached for participation.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Pennsylvania
-
Danville, Pennsylvania, Vereinigte Staaten, 17822
- Geisinger Health System
-
-
Rhode Island
-
Providence, Rhode Island, Vereinigte Staaten, 02905
- Women & Infants Hospital
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- The University of Texas Health Science Center, Houston
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
- Singleton pregnancies
- Maternal age over 18 years
- Patients able to read and write in English or Spanish,
- Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
- Patients identified as not requiring medical therapy (insulin or glyburide) after the first week of initial blood glucose monitoring.
Exclusion Criteria:
- Diagnosis of GDM made by any method or criteria other than the one outlined above
- Women with pre-existing diabetes mellitus
- Patients under the age of 18 years
- Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
- Patients carrying multiple gestations
- Patients with past history of gastric bypass
- Patients with poorly controlled asthma, defined as the need for oral/inhaled corticosteroids to control symptoms
- Patients with chronic hypertension requiring medical therapy
- Patients currently on methadone/suboxone therapy
- Patients currently on any steroid therapy, regardless of the dose or route of administration
- Patients demonstrating poor compliance during the first week of initial blood glucose monitoring, defined as <20% of expected values actually recorded during the one-week period of initial monitoring
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Every day blood glucose testing
Patients will test their blood glucose values 4 times every day
|
|
Experimental: Every other day blood glucose testing
Patients will test their blood glucose 4 times every other day
|
Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Neonatal weight
Zeitfenster: At birth
|
In patients with GDM, every other day blood glucose testing is non-inferior to every day blood glucose testing, as measured by the difference of less than 5% in birth weight
|
At birth
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Macrosomia
Zeitfenster: At birth
|
To determine if every other day testing is associated with a greater rate of macrosomia, defined as birth weight > 4,000 grams, than every day blood glucose testing
|
At birth
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Hector Mendez-Figueroa, M.D., The University of Texas Health Science Center, Houston
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HSC-MS-13-0719
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Schwangerschaftsdiabetes
-
Sansum Diabetes Research InstituteRekrutierungDiabetes mellitus, Typ 2 | Diabetes Mel Gestational – in der SchwangerschaftVereinigte Staaten
-
Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... und andere MitarbeiterSuspendiertSchwangerschaftskomplikationen | Fettleibigkeit, mütterlicherseits | Diabetes Mel Gestational – in der SchwangerschaftBrasilien
-
University of Colorado, DenverAbgeschlossenPräeklampsie | Schwangerschaftsdiabetes mellitus | Schwangerschafts-Hypertonie | Frühzeitige Lieferung | Geburt eines SGA-Babys (Small for Gestational Age).Vereinigte Staaten
Klinische Studien zur Blood glucose testing
-
Wake Forest University Health SciencesAbgeschlossen
-
Washington University School of MedicineThe Foundation for Barnes-Jewish HospitalBeendetLynch-Syndrom | Erblicher Brust- und EierstockkrebsVereinigte Staaten
-
Northwell HealthGenomind, LLCAbgeschlossenPsychotische Störungen | Schizophrenie | Schizoaffektiven Störung | Schizophreniforme Störung | Bipolare StörungVereinigte Staaten
-
San Diego State UniversityNational Cancer Institute (NCI)Rekrutierung
-
Buddhist Tzu Chi General HospitalAbgeschlossen
-
University of FloridaCureDuchenneAbgeschlossenMuskeldystrophie, DuchenneVereinigte Staaten
-
Cerus CorporationRekrutierungAnämieVereinigte Staaten, Puerto Rico
-
Haydarpasa Numune Training and Research HospitalAbgeschlossenBlutgerinnungsstörungTruthahn
-
The Cleveland ClinicNoch keine RekrutierungPränatale StörungVereinigte Staaten
-
University Hospital, RouenNoch keine RekrutierungHepatitis B | Hepatitis C | AIDSFrankreich