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Real-time Continuous Glucose Monitoring

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ClinicalTrials.gov Identifier: NCT03326232
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Eastern Virginia Medical School

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Device: Continuous glucose monitoring Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Blinded continuous glucose monitoring
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).
Device: Continuous glucose monitoring
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)

Experimental: 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)
Device: Continuous glucose monitoring
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)




Primary Outcome Measures :
  1. Mean blood glucose (mg/dL) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Failed dietary therapy [ Time Frame: week 1 vs. week 4 ]
    Failed dietary therapy (started on medication),

  2. Time spent in normoglycemia [ Time Frame: week 1 vs. week 4 ]
    Time spent in normoglycemia (min/day)

  3. Time spent in hypoglycemia [ Time Frame: week 1 vs. week 4 ]
    Time spent in hypoglycemia (min/day)

  4. BMI at time of delivery [ Time Frame: BMI at time of delivery ]
    BMI at time of delivery (kg/m2)

  5. Gestational hypertension [ Time Frame: 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

  6. Preeclampsia [ Time Frame: 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

  7. HbA1C values [ Time Frame: HbA1C values week 1 compared to week 4 (%) ]
    HbA1C values (%)

  8. Polyhydramnios [ Time Frame: Through study completion, an average of 9 months ]
    Polyhydramnios (MVP > 8 cm at any point in the pregnancy)

  9. Cesarean delivery [ Time Frame: Delivery ]
    Cesarean delivery (w/ indication: macrosomia, malpresentation, failed induction, fetal distress, failed trial of labor after cesarean, scheduled repeat, other)

  10. Induction of labor [ Time Frame: Delivery ]
    Induction of labor (w/ indication)

  11. Operative vaginal delivery [ Time Frame: Delivery ]
    Operative vaginal delivery (yes/no) and type (forceps/vacuum)

  12. Shoulder dystocia [ Time Frame: Delivery ]
    Shoulder dystocia (diagnosed clinically)

  13. Fetal macrosomia [ Time Frame: Most recent ultrasound before delivery ]
    Fetal macrosomia (> 4,000g at 38 wk u/s)

  14. 3rd or 4th degree perineal laceration [ Time Frame: Delivery ]
    3rd or 4th degree perineal laceration at time of delivery

  15. Gestational age at delivery [ Time Frame: Delivery ]
    Gestational age at delivery (weeks, days)

  16. Preterm delivery [ Time Frame: Delivery ]
    Preterm delivery (< 37 weeks gestational age at birth)

  17. Birth weight [ Time Frame: Delivery ]
    Birth weight (grams)

  18. Perinatal morbidity composite outcome [ Time Frame: Delivery ]
    • Hypoglycemia (yes/no): < 2 hrs after birth and before feeding, defined as < 35mg/dL
    • Hyperbilirubinemia (yes/no): collected 16-36 hrs after birth, defined as > 95% for any given point after birth requiring phototherapy according to American Academy of Pediatrics guidelines
    • Birth trauma (yes/no): brachial plexus injury or clavicular, humeral, or skull fracture
    • Intrauterine fetal demise or neonatal death (yes/no): prior to hospital discharge

  19. Large for gestational age [ Time Frame: Delivery ]
    Large for gestational age (yes/no): defined as birth weight > 90%

  20. Small for gestational age [ Time Frame: Delivery ]
    Small for gestational age (yes/no): defined as birth weight < 10%

  21. Admission to neonatal intensive care unit [ Time Frame: Delivery ]
    Admission to neonatal intensive care unit (yes/no) and length of neonatal intensive care unit stay (days)

  22. Respiratory distress syndrome [ Time Frame: Delivery ]
    Respiratory distress syndrome (defined as need to supplemental oxygen > 4 hrs after birth)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females with gestational diabetes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326232


Contacts
Contact: Joanne Audouin, MS 757-446-5121 audouij@evms.edu
Contact: Andrew Lane, MD 864-608-4134 laneas@evms.edu

Locations
United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: Joanne Audouin, MS    757-446-5121    audouij@evms.edu   
Contact: Andrew Lane, MD    864-608-4134    laneas@evms.edu   
Principal Investigator: Malgorzata Mlynarczyk, MD, PhD         
Sub-Investigator: Andrew Lane, MD         
Sub-Investigator: Margarita de Veciana, MD         
Sub-Investigator: Alfred Abuhamad, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Medtronic
Investigators
Principal Investigator: Malgorzata Mlynarczyk, MD, PhD Eastern Virginia Medical School
  Study Documents (Full-Text)

Documents provided by Eastern Virginia Medical School:
Study Protocol  [PDF] September 27, 2017


Publications:

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03326232     History of Changes
Other Study ID Numbers: 17-07-FB-0181
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not plan to share.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases