Real-time Continuous Glucose Monitoring
2017年11月21日 更新者：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
研究概览
详细说明
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
研究类型
介入性
注册 (预期的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Joanne Audouin, MS
- 电话号码：757-446-5121
- 邮箱：audouij@evms.edu
研究联系人备份
- 姓名：Andrew Lane, MD
- 电话号码：864-608-4134
- 邮箱：laneas@evms.edu
学习地点
-
-
Virginia
-
Norfolk、Virginia、美国、23507
- 招聘中
- Eastern Virginia Medical School
-
副研究员：
- Alfred Abuhamad, MD
-
接触：
- Joanne Audouin, MS
- 电话号码：757-446-5121
- 邮箱：audouij@evms.edu
-
接触：
- Andrew Lane, MD
- 电话号码：864-608-4134
- 邮箱：laneas@evms.edu
-
首席研究员：
- Malgorzata Mlynarczyk, MD, PhD
-
副研究员：
- Andrew Lane, MD
-
副研究员：
- Margarita de Veciana, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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)
|
|
实验性的：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)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean blood glucose (mg/dL)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Failed dietary therapy
大体时间：week 1 vs. week 4
|
Failed dietary therapy (started on medication),
|
week 1 vs. week 4
|
|
Time spent in normoglycemia
大体时间：week 1 vs. week 4
|
Time spent in normoglycemia (min/day)
|
week 1 vs. week 4
|
|
Time spent in hypoglycemia
大体时间：week 1 vs. week 4
|
Time spent in hypoglycemia (min/day)
|
week 1 vs. week 4
|
|
BMI at time of delivery
大体时间：BMI at time of delivery
|
BMI at time of delivery (kg/m2)
|
BMI at time of delivery
|
|
Gestational hypertension
大体时间：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
大体时间：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
大体时间：HbA1C values week 1 compared to week 4 (%)
|
HbA1C values (%)
|
HbA1C values week 1 compared to week 4 (%)
|
|
Polyhydramnios
大体时间：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
大体时间：Delivery
|
Cesarean delivery (w/ indication: macrosomia, malpresentation, failed induction, fetal distress, failed trial of labor after cesarean, scheduled repeat, other)
|
Delivery
|
|
Induction of labor
大体时间：Delivery
|
Induction of labor (w/ indication)
|
Delivery
|
|
Operative vaginal delivery
大体时间：Delivery
|
Operative vaginal delivery (yes/no) and type (forceps/vacuum)
|
Delivery
|
|
Shoulder dystocia
大体时间：Delivery
|
Shoulder dystocia (diagnosed clinically)
|
Delivery
|
|
Fetal macrosomia
大体时间：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
大体时间：Delivery
|
3rd or 4th degree perineal laceration at time of delivery
|
Delivery
|
|
Gestational age at delivery
大体时间：Delivery
|
Gestational age at delivery (weeks, days)
|
Delivery
|
|
Preterm delivery
大体时间：Delivery
|
Preterm delivery (< 37 weeks gestational age at birth)
|
Delivery
|
|
Birth weight
大体时间：Delivery
|
Birth weight (grams)
|
Delivery
|
|
Perinatal morbidity composite outcome
大体时间：Delivery
|
|
Delivery
|
|
Large for gestational age
大体时间：Delivery
|
Large for gestational age (yes/no): defined as birth weight > 90%
|
Delivery
|
|
Small for gestational age
大体时间：Delivery
|
Small for gestational age (yes/no): defined as birth weight < 10%
|
Delivery
|
|
Admission to neonatal intensive care unit
大体时间：Delivery
|
Admission to neonatal intensive care unit (yes/no) and length of neonatal intensive care unit stay (days)
|
Delivery
|
|
Respiratory distress syndrome
大体时间：Delivery
|
Respiratory distress syndrome (defined as need to supplemental oxygen > 4 hrs after birth)
|
Delivery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Malgorzata Mlynarczyk, MD, PhD、Eastern Virginia Medical School
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月13日
初级完成 (预期的)
2018年7月1日
研究完成 (预期的)
2018年7月1日
研究注册日期
首次提交
2017年10月25日
首先提交符合 QC 标准的
2017年10月27日
首次发布 (实际的)
2017年10月31日
研究记录更新
最后更新发布 (实际的)
2017年11月24日
上次提交的符合 QC 标准的更新
2017年11月21日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Continuous glucose monitoring的临床试验
-
Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom完全的
-
Cline Research CenterAbbott Diabetes Care完全的
-
University of AarhusOdense University Hospital; Aarhus University Hospital; Protac A/S; Innovation Fund Denmark招聘中