Real-time Continuous Glucose Monitoring
21. november 2017 opdateret af: Eastern Virginia Medical School
Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy.
The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes.
GDM places the pregnancy at great risk to both the mother and the neonate.
Recent studies have proven that interventions including dietary and medications lower the risk to the pregnancy.
Both the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment of choice.
Meanwhile, outside of pregnancy, promising new technologies such as continuous glucose monitors (CGM) are revolutionizing diabetic care.
The investigators seek to determine if the constant feedback of a real-time CGM system would improve glycemic control compared to traditional management in GDM
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM.
First, most studies only use CGM for 48 - 72hours at a time, while the investigators will be using CGM for 7 day intervals.
Both groups will use the same Enlite sensor (Medtronic).
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter).
The real-time CGM group will be using the 530g system (iPro2 (Enlite sensor + transmitter) + inactivated 530g pump set only to display glucose values, no insulin will be administered).
This CGM system has been FDA approved to for up to 7 days between sensor changes.26,27
Second, no previous study has used real time CGM in pregnant patients with GDM in the US.
The investigators will be the first to describe the use of this technology in this patient population.
Third, most of these trials have been performed on populations that are not representative of the investigators' patient population at EVMS.
This will be the largest US study of CGM in GDM.
Fourth wearable medical and fitness technology is already popular, but as both the technology and the demand continues to grow, it will become the future of diabetes management.
Studies have already shown that real time CGM is an effective educational and motivational tool in type-1 and type-2 DM.28,29
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23507
- Rekruttering
- Eastern Virginia Medical School
-
Underforsker:
- Alfred Abuhamad, MD
-
Kontakt:
- Joanne Audouin, MS
- Telefonnummer: 757-446-5121
- E-mail: audouij@evms.edu
-
Kontakt:
- Andrew Lane, MD
- Telefonnummer: 864-608-4134
- E-mail: laneas@evms.edu
-
Ledende efterforsker:
- Malgorzata Mlynarczyk, MD, PhD
-
Underforsker:
- Andrew Lane, MD
-
Underforsker:
- Margarita de Veciana, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- maternal age 18 to 45
- singleton gestation
- gestational age less than 32 weeks gestation at study inclusion
- BMI less than 45
- 50g glucose challenge greater than 135 mg/dL
- 100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
- attended the maternal-fetal medicine diabetes education class
Exclusion Criteria:
- maternal age less than18 or greater than 45
- multifetal gestation
- gestational age greater than 32 weeks study inclusion
- BMI greater than 45
- pregestational diabetes
- gestational diabetes diagnosed before 24 weeks
- did not attend the diabetes education class
- known fetal anomaly
- known fetal aneuploidy
- required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
- learning disability
- concern for non compliance with medical care
- imminent preterm delivery due to maternal disease or fetal conditions
- is not willing to wear CGM
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Blinded continuous glucose monitoring
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).
|
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).
The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
|
|
Eksperimentel: Real time continuous glucose monitoring
The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
|
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).
The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean blood glucose (mg/dL)
Tidsramme: week 1 vs. week 4
|
Mean blood glucose (mg/dL) in the real-time CGM group compared to self-monitoring of blood glucose (SMBG) group during the 4th week of study from data collected on the 6 day of CGM use during that week.
|
week 1 vs. week 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Failed dietary therapy
Tidsramme: week 1 vs. week 4
|
Failed dietary therapy (started on medication),
|
week 1 vs. week 4
|
|
Time spent in normoglycemia
Tidsramme: week 1 vs. week 4
|
Time spent in normoglycemia (min/day)
|
week 1 vs. week 4
|
|
Time spent in hypoglycemia
Tidsramme: week 1 vs. week 4
|
Time spent in hypoglycemia (min/day)
|
week 1 vs. week 4
|
|
BMI at time of delivery
Tidsramme: BMI at time of delivery
|
BMI at time of delivery (kg/m2)
|
BMI at time of delivery
|
|
Gestational hypertension
Tidsramme: enrollement vs delivery.
|
Gestational hypertension (defined as systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mmg Hg, on 2 occasions at least 4 hrs apart
|
enrollement vs delivery.
|
|
Preeclampsia
Tidsramme: enrollement vs delivery.
|
Preeclampsia (defined as gestational hypertension plus either new-onset proteinuria (> 300 mg/24 2hrs, protein:creatinine > 0.3 mg/dL), thrombocytopenia (platelet count < 100,000/uL), elevated Aspartate aminotransferase or alanine aminotransferase (> 2x upper limit of normal), renal insufficiency (serum creatinine > 1.1 mg/dL or an unexplained doubling of creatinine), pulmonary edema, or cerebral or visual symptoms
|
enrollement vs delivery.
|
|
HbA1C values
Tidsramme: HbA1C values week 1 compared to week 4 (%)
|
HbA1C values (%)
|
HbA1C values week 1 compared to week 4 (%)
|
|
Polyhydramnios
Tidsramme: Through study completion, an average of 9 months
|
Polyhydramnios (MVP > 8 cm at any point in the pregnancy)
|
Through study completion, an average of 9 months
|
|
Cesarean delivery
Tidsramme: Delivery
|
Cesarean delivery (w/ indication: macrosomia, malpresentation, failed induction, fetal distress, failed trial of labor after cesarean, scheduled repeat, other)
|
Delivery
|
|
Induction of labor
Tidsramme: Delivery
|
Induction of labor (w/ indication)
|
Delivery
|
|
Operative vaginal delivery
Tidsramme: Delivery
|
Operative vaginal delivery (yes/no) and type (forceps/vacuum)
|
Delivery
|
|
Shoulder dystocia
Tidsramme: Delivery
|
Shoulder dystocia (diagnosed clinically)
|
Delivery
|
|
Fetal macrosomia
Tidsramme: Most recent ultrasound before delivery
|
Fetal macrosomia (> 4,000g at 38 wk u/s)
|
Most recent ultrasound before delivery
|
|
3rd or 4th degree perineal laceration
Tidsramme: Delivery
|
3rd or 4th degree perineal laceration at time of delivery
|
Delivery
|
|
Gestational age at delivery
Tidsramme: Delivery
|
Gestational age at delivery (weeks, days)
|
Delivery
|
|
Preterm delivery
Tidsramme: Delivery
|
Preterm delivery (< 37 weeks gestational age at birth)
|
Delivery
|
|
Birth weight
Tidsramme: Delivery
|
Birth weight (grams)
|
Delivery
|
|
Perinatal morbidity composite outcome
Tidsramme: Delivery
|
|
Delivery
|
|
Large for gestational age
Tidsramme: Delivery
|
Large for gestational age (yes/no): defined as birth weight > 90%
|
Delivery
|
|
Small for gestational age
Tidsramme: Delivery
|
Small for gestational age (yes/no): defined as birth weight < 10%
|
Delivery
|
|
Admission to neonatal intensive care unit
Tidsramme: Delivery
|
Admission to neonatal intensive care unit (yes/no) and length of neonatal intensive care unit stay (days)
|
Delivery
|
|
Respiratory distress syndrome
Tidsramme: Delivery
|
Respiratory distress syndrome (defined as need to supplemental oxygen > 4 hrs after birth)
|
Delivery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Malgorzata Mlynarczyk, MD, PhD, Eastern Virginia Medical School
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Gillman MW, Rifas-Shiman S, Berkey CS, Field AE, Colditz GA. Maternal gestational diabetes, birth weight, and adolescent obesity. Pediatrics. 2003 Mar;111(3):e221-6. doi: 10.1542/peds.111.3.e221.
- Correa A, Bardenheier B, Elixhauser A, Geiss LS, Gregg E. Trends in prevalence of diabetes among delivery hospitalizations, United States, 1993-2009. Matern Child Health J. 2015 Mar;19(3):635-42. doi: 10.1007/s10995-014-1553-5.
- Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.
- Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.
- Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
- Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
- Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.
- de Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995 Nov 9;333(19):1237-41. doi: 10.1056/NEJM199511093331901.
- HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013 Aug;122(2 Pt 1):406-416. doi: 10.1097/01.AOG.0000433006.09219.f1.
- Moyer VA; U.S. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 18;160(6):414-20. doi: 10.7326/M13-2905.
- England LJ, Dietz PM, Njoroge T, Callaghan WM, Bruce C, Buus RM, Williamson DF. Preventing type 2 diabetes: public health implications for women with a history of gestational diabetes mellitus. Am J Obstet Gynecol. 2009 Apr;200(4):365.e1-8. doi: 10.1016/j.ajog.2008.06.031. Epub 2008 Aug 8.
- Malcolm JC, Lawson ML, Gaboury I, Lough G, Keely E. Glucose tolerance of offspring of mother with gestational diabetes mellitus in a low-risk population. Diabet Med. 2006 May;23(5):565-70. doi: 10.1111/j.1464-5491.2006.01840.x.
- Mastrototaro J, Shin J, Marcus A, Sulur G; STAR 1 Clinical Trial Investigators. The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):385-90. doi: 10.1089/dia.2007.0291.
- Kestila KK, Ekblad UU, Ronnemaa T. Continuous glucose monitoring versus self-monitoring of blood glucose in the treatment of gestational diabetes mellitus. Diabetes Res Clin Pract. 2007 Aug;77(2):174-9. doi: 10.1016/j.diabres.2006.12.012. Epub 2007 Jan 16.
- Moy FM, Ray A, Buckley BS. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2014 Apr 30;(4):CD009613. doi: 10.1002/14651858.CD009613.pub2.
- Porter H, Lookinland S, Belfort MA. Evaluation of a new real-time blood continuous glucose monitoring system in pregnant women without gestational diabetes. A pilot study. J Perinat Neonatal Nurs. 2004 Apr-Jun;18(2):93-102. doi: 10.1097/00005237-200404000-00004.
- McLachlan K, Jenkins A, O'Neal D. The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. Aust N Z J Obstet Gynaecol. 2007 Jun;47(3):186-90. doi: 10.1111/j.1479-828X.2007.00716.x.
- Yu F, Lv L, Liang Z, Wang Y, Wen J, Lin X, Zhou Y, Mai C, Niu J. Continuous glucose monitoring effects on maternal glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus: a prospective cohort study. J Clin Endocrinol Metab. 2014 Dec;99(12):4674-82. doi: 10.1210/jc.2013-4332.
- Alfadhli E, Osman E, Basri T. Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. Diabetol Metab Syndr. 2016 Jul 26;8:48. doi: 10.1186/s13098-016-0161-5. eCollection 2016.
- Glowinska-Olszewska B, Tobiaszewska M, Luczynski W, Bossowski A. Monthly use of a real-time continuous glucose monitoring system as an educational and motivational tool for poorly controlled type 1 diabetes adolescents. Adv Med Sci. 2013;58(2):344-52. doi: 10.2478/ams-2013-0024.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. november 2017
Primær færdiggørelse (Forventet)
1. juli 2018
Studieafslutning (Forventet)
1. juli 2018
Datoer for studieregistrering
Først indsendt
25. oktober 2017
Først indsendt, der opfyldte QC-kriterier
27. oktober 2017
Først opslået (Faktiske)
31. oktober 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-07-FB-0181
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Do not plan to share.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Svangerskabsdiabetes
-
xiang yangRekrutteringGestationel trofoblastisk tumor | Gestationel trofoblastisk neoplasi | Choriocarcinom | Fase I Gestational trofoblastisk tumor | Fase II Gestational trofoblastisk tumor | Fase III Gestational trofoblastisk tumor | Invasiv muldvarpKina
-
GOG FoundationNational Cancer Institute (NCI)AfsluttetHydatidiform muldvarp | Choriocarcinom | FIGO Stage I Gestational trofoblastisk tumor | FIGO Stage II Gestational trofoblastisk tumor | FIGO Stage III Gestational trofoblastisk tumorForenede Stater, Korea, Republikken, Canada, Japan, Det Forenede Kongerige
-
Azienda Ospedaliero Universitaria Maggiore della...AfsluttetKardiovaskulære abnormiteter | Lille-til-gestational alderItalien
-
Carmel Medical CenterUkendtMissed Abort | Ufuldstændig abort | Uterin Gestational Rester | Uterin arterie DopplerIsrael
-
Sansum Diabetes Research InstituteRekrutteringDiabetes mellitus, type 2 | Diabetes Mel Gestational - under graviditetForenede Stater
-
Johns Hopkins Bloomberg School of Public HealthJiVitA Project, Gaibandha, BangladeshAfsluttetFor tidlig fødsel | Fødselsvægt | Abort | Lille-til-gestational alderBangladesh
-
Centre Hospitalier Universitaire de BesanconUniversity Hospital, Strasbourg, France; Centre Hospitalier Universitaire... og andre samarbejdspartnereUkendtIntrauterin vækstrestriktion | Lille-til-gestational alder
-
Assistance Publique - Hôpitaux de ParisAfsluttet
-
PfizerAfsluttetShort Statur Born Small for Gestational Age (SGA)Japan
-
International Food Policy Research InstituteAfsluttetFor tidlig fødsel | Lille-til-gestational alder | Dårlig fostervækstForenede Stater
Kliniske forsøg med Continuous glucose monitoring
-
Beijing Tsinghua Chang Gung HospitalThe First Affiliated Hospital of Anhui Medical University; Beijing Tiantan... og andre samarbejdspartnereRekrutteringOmfattende komplikationsindeksKina
-
Abbott Diabetes CareLiverpool University Hospitals NHS Foundation Trust; NHS Lothian; Cardiff... og andre samarbejdspartnereAfsluttetDiabetes mellitusDet Forenede Kongerige
-
Barnev LtdAfsluttetArbejdskraft | ObstetrikIsrael
-
Abbott Diabetes CareAfsluttetDiabetes mellitusForenede Stater
-
University of the PacificRekrutteringType 1 diabetes | Type 2 diabetesForenede Stater
-
Medical University of ViennaRekrutteringGraviditetskomplikationer | Blodsukker | Svangerskabsdiabetes | GDM | CgmØstrig
-
Medical Research Foundation, The NetherlandsMedtronicAfsluttetGlukosemetabolismeforstyrrelser | Perioperativ plejeHolland
-
University Hospital Bispebjerg and FrederiksbergZealand University Hospital; Rigshospitalet, Denmark; Steno Diabetes Center...RekrutteringDiabetes mellitus | Dysglykæmi | Perioperativ komplikation | Kredsløb; KomplikationerDanmark
-
Christian S. MeyhoffZealand University Hospital; Rigshospitalet, Denmark; Steno Diabetes Center...Ikke rekrutterer endnuEffekten af kontinuerlig glukosemonitorering hos kirurgiske patienter med diabetes. (WARD-glucose)Diabetes mellitus | Dysglykæmi | Perioperativ komplikationDanmark
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCAfsluttetType 2 diabetes mellitus | Type 1 diabetes mellitusForenede Stater