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Glycemic Targets for Pregnant Women With GDM and T2DM

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ClinicalTrials.gov Identifier: NCT04672031
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Richard H. Lee, University of Southern California

Brief Summary:
The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus in Pregnancy Diabetes, Gestational Diabetes Mellitus, Type 2 Other: Glycemic Targets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible women will be randomized at a 1:1 ratio (using block randomization) into either the control arm or the intervention arm. It is understood that study participants, physicians, and nurse-educators cannot be blinded to group allocation. The randomization process will proceed as follows. A primary randomization model assigning patients to the "New Target" versus the "Standard Target" will be created for the one center (LAC+USC), and permuted-block randomization with random allocation will be used. The investigators will be blinded to the block size. The generation of randomization codes will be performed using SAS statistical software, v. 9.3, Cary, NC. A validation test will be performed to assure that treatment balance is achieved within the entire study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
No Intervention: Control Arm
Patients in the control arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL (i.e. conventional targets). Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.
Experimental: Interventional Arm
Patients in the experimental arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.
Other: Glycemic Targets
The intervention is glycemic targets that are lower than those currently recommended by ADA and ACOG: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL instead of fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL.




Primary Outcome Measures :
  1. Difference in birth weight [ Time Frame: 41 weeks gestation ]
    250-gram difference in birth weight


Secondary Outcome Measures :
  1. Total prenatal care visits [ Time Frame: 41 weeks gestation ]
    Total number of prenatal care visits during pregnancy

  2. Prenatal care visits after enrollment [ Time Frame: 41 weeks gestation ]
    Number of prenatal care visits after enrollment

  3. Prenatal care visits: log/glucometer [ Time Frame: 41 weeks gestation ]
    Number of prenatal care visits with log/glucometer available for RN or MD to review

  4. Prenatal care visits: targets met [ Time Frame: 41 weeks gestation ]
    Number of prenatal care visits in which patient met blood sugar targets

  5. Prenatal care visits: intervention [ Time Frame: 41 weeks gestation ]
    Number of prenatal care visits in which an intervention for blood sugars was recommended (e.g. starting medication or changing medication dose)

  6. Symptomatic hypoglycemia [ Time Frame: 41 weeks gestation ]
    Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)

  7. Asymptomatic hypoglycemia [ Time Frame: 41 weeks gestation ]
    Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)

  8. A1c enrollment [ Time Frame: At time of enrollment (up to 34 weeks gestation) ]
    Hemoglobin A1c at the time of enrollment

  9. A1c 36 weeks [ Time Frame: At 36 weeks gestational age ]
    Hemoglobin A1c at 36 weeks gestational age

  10. Lowest recorded blood sugar [ Time Frame: 41 weeks gestation ]
    Lowest recorded blood sugar during prenatal care

  11. Highest recorded blood sugar [ Time Frame: 41 weeks gestation ]
    Highest recorded blood sugar during prenatal care

  12. Average recorded blood sugar [ Time Frame: 41 weeks gestation ]
    Average recorded blood sugar during prenatal care

  13. Weekly compliance [ Time Frame: 41 weeks gestation ]
    Average number of blood sugar checks actually performed each week

  14. Weekly target assessment [ Time Frame: 41 weeks gestation ]
    % of blood sugars within goal each week

  15. Diabetes medication [ Time Frame: 41 weeks gestation ]
    Did the patient need diabetes medication (including oral agents and insulin) during antepartum period?

  16. Intrapartum insulin [ Time Frame: From onset of induction/labor until delivery ]
    Did the patient need insulin during the intrapartum period?

  17. Gestational weight gain [ Time Frame: 41 weeks gestation ]
    Total weight gain during pregnancy in kilograms

  18. Antepartum admission [ Time Frame: 41 weeks gestation ]
    Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication?

  19. Corticosteroids [ Time Frame: 41 weeks gestation ]
    Did the patient receive antenatal corticosteroid treatment?

  20. Oligohydramnios [ Time Frame: 41 weeks gestation ]
    Amniotic fluid index <5 cm or maximum vertical pocket <2cm

  21. Polyhydramnios [ Time Frame: 41 weeks gestation ]
    Amniotic fluid index >24cm or maximum vertical pocket >8cm

  22. Fetal growth restriction [ Time Frame: 41 weeks gestation ]
    Ultrasonographic estimated fetal weight or abdominal circumference <10% for gestational ag

  23. Gestational age at delivery [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Gestational age at delivery

  24. Induction of labor [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Did the patient undergo induction of labor?

  25. Mode of delivery [ Time Frame: During intrapartum admission to Labor & Delivery ]
    primary cesarean section, repeat cesarean section, vaginal delivery, vaginal delivery with vacuum, vaginal delivery with forceps

  26. Cesarean indication [ Time Frame: During intrapartum admission to Labor & Delivery ]
    If the patient had cesarean delivery, what was the indication?

  27. TOLAC [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Did the patient attempt a trial of labor after cesarean?

  28. Blood loss [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Quantitative blood loss (or estimated if quantitative is unknown) in cc's

  29. 3rd or 4th degree laceration [ Time Frame: During intrapartum admission to Labor & Delivery ]
    3rd or 4th degree perineal laceration

  30. PIH [ Time Frame: From 20 weeks gestation until 30 days postpartum ]
    Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome)

  31. Hypertensive emergency [ Time Frame: From conception until 30 days postpartum ]
    Did the patient have severe-range blood pressures require antihypertensive medication?

  32. Chorioamnionitis [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Chorioamnionitis

  33. Endometritis [ Time Frame: Within 30 days postpartum ]
    Endometritis

  34. VTE [ Time Frame: From conception until 30 days postpartum ]
    Venous thromboembolism: deep venous thrombosis or pulmonary embolism

  35. Length of stay (maternal) [ Time Frame: From admission to Labor & Delivery until discharge from postpartum ]
    Length of hospital admission for labor, delivery, and postpartum

  36. Postpartum readmission [ Time Frame: Within 30 days postpartum ]
    Did the patient get readmitted within 30 days of delivery?

  37. Postpartum wound complication [ Time Frame: Within 30 days postpartum ]
    Cesarean wound infection of dehiscence, perineal laceration breakdown

  38. Cardiac complications [ Time Frame: From conception until 30 days postpartum ]
    Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy?

  39. Seizures [ Time Frame: From conception until 30 days postpartum ]
    Did any maternal seizures occur during the pregnancy or postpartum?

  40. Macrosomia [ Time Frame: Within 24 hours of birth ]
    Birth weight >4000 grams

  41. LGA [ Time Frame: Within 24 hours of birth ]
    Large for gestational age (birth weight ≥90% for gestational age)

  42. SGA [ Time Frame: Within 24 hours of birth ]
    Small for gestational age (birth weight <10% for gestational age)

  43. Shoulder dystocia [ Time Frame: During intrapartum admission to Labor & Delivery ]
    Shoulder dystocia

  44. Apgar [ Time Frame: 5 minutes after birth ]
    5-minute Apgar score

  45. Cord gas pH <7.0 [ Time Frame: Within 24 hours of birth ]
    Did the baby have a cord blood gas pH <7.0?

  46. Base excess [ Time Frame: Within 24 hours of birth ]
    What was the base excess on the cord blood gas?

  47. Neonatal blood glucose [ Time Frame: Within 24 hours of birth ]
    What was the neonatal serum blood glucose at birth?

  48. RDS [ Time Frame: Within 30 days of delivery ]
    Neonatal respiratory distress syndrome

  49. TTN [ Time Frame: Within 30 days of delivery ]
    Transient tachypnea of the newborn

  50. Hyperbilirubinemia [ Time Frame: Within 30 days of delivery ]
    Neonatal hyperbilirubinemia (as defined in AAP 2004 Clinical Practice Guideline "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation")

  51. Neonatal sepsis [ Time Frame: Within 30 days of delivery ]
    Neonatal sepsis

  52. NICU [ Time Frame: Within 30 days of delivery ]
    NICU admission

  53. Length of stay (neonatal) [ Time Frame: From birth until discharge (up to 1 year) ]
    How many days after birth did the neonate stay in the hospital?

  54. Congenital anomaly [ Time Frame: Within 30 days of delivery ]
    Congenital anomaly

  55. IUFD or stillbirth [ Time Frame: From conception until delivery ]
    Intrauterine fetal demise or stillbirth



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women with a singleton gestation
  • 18 years or older
  • Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes

Exclusion Criteria:

  • Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
  • Type 1 diabetes
  • Diabetic retinopathy
  • Diabetic nephropathy
  • Diabetic vasculopathy

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): NCT04672031


Contacts
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Contact: Michelle T Nguyen, MD 323-409-4084 michelle.nguyen3@med.usc.edu

Locations
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United States, California
Los Angeles County + University of Southern California Medical Center (LAC+USC)
Los Angeles, California, United States, 90033
Contact: Michelle T Nguyen, MD    323-409-4084    michelle.nguyen3@med.usc.edu   
Sponsors and Collaborators
Richard H. Lee
Publications of Results:
Other Publications:

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Responsible Party: Richard H. Lee, Faculty Sponsor, University of Southern California
ClinicalTrials.gov Identifier: NCT04672031    
Other Study ID Numbers: APP-20-06210
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications