Clinical trial NCT04672031: Glycemic Targets for Pregnant Women With GDM and T2DM
Official title: Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus in Pregnancy
Diabetes, Gestational
Diabetes Mellitus, Type 2
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Difference in birth weight
timeFrame: 41 weeks gestation
Secondary outcomes:
measure: Total prenatal care visits
timeFrame: 41 weeks gestation
measure: Prenatal care visits after enrollment
timeFrame: 41 weeks gestation
measure: Prenatal care visits: log/glucometer
timeFrame: 41 weeks gestation
measure: Prenatal care visits: targets met
timeFrame: 41 weeks gestation
measure: Prenatal care visits: intervention
timeFrame: 41 weeks gestation
measure: Symptomatic hypoglycemia
timeFrame: 41 weeks gestation
measure: Asymptomatic hypoglycemia
timeFrame: 41 weeks gestation
measure: A1c enrollment
timeFrame: At time of enrollment (up to 34 weeks gestation)
measure: A1c 36 weeks
timeFrame: At 36 weeks gestational age
measure: Lowest recorded blood sugar
timeFrame: 41 weeks gestation
measure: Highest recorded blood sugar
timeFrame: 41 weeks gestation
measure: Average recorded blood sugar
timeFrame: 41 weeks gestation
measure: Weekly compliance
timeFrame: 41 weeks gestation
measure: Weekly target assessment
timeFrame: 41 weeks gestation
measure: Diabetes medication
timeFrame: 41 weeks gestation
measure: Intrapartum insulin
timeFrame: From onset of induction/labor until delivery
measure: Gestational weight gain
timeFrame: 41 weeks gestation
measure: Antepartum admission
timeFrame: 41 weeks gestation
measure: Corticosteroids
timeFrame: 41 weeks gestation
measure: Oligohydramnios
timeFrame: 41 weeks gestation
measure: Polyhydramnios
timeFrame: 41 weeks gestation
measure: Fetal growth restriction
timeFrame: 41 weeks gestation
measure: Gestational age at delivery
timeFrame: During intrapartum admission to Labor & Delivery
measure: Induction of labor
timeFrame: During intrapartum admission to Labor & Delivery
measure: Mode of delivery
timeFrame: During intrapartum admission to Labor & Delivery
measure: Cesarean indication
timeFrame: During intrapartum admission to Labor & Delivery
measure: TOLAC
timeFrame: During intrapartum admission to Labor & Delivery
measure: Blood loss
timeFrame: During intrapartum admission to Labor & Delivery
measure: 3rd or 4th degree laceration
timeFrame: During intrapartum admission to Labor & Delivery
measure: PIH
timeFrame: From 20 weeks gestation until 30 days postpartum
measure: Hypertensive emergency
timeFrame: From conception until 30 days postpartum
measure: Chorioamnionitis
timeFrame: During intrapartum admission to Labor & Delivery
measure: Endometritis
timeFrame: Within 30 days postpartum
measure: VTE
timeFrame: From conception until 30 days postpartum
measure: Length of stay (maternal)
timeFrame: From admission to Labor & Delivery until discharge from postpartum
measure: Postpartum readmission
timeFrame: Within 30 days postpartum
measure: Postpartum wound complication
timeFrame: Within 30 days postpartum
measure: Cardiac complications
timeFrame: From conception until 30 days postpartum
measure: Seizures
timeFrame: From conception until 30 days postpartum
measure: Macrosomia
timeFrame: Within 24 hours of birth
measure: LGA
timeFrame: Within 24 hours of birth
measure: SGA
timeFrame: Within 24 hours of birth
measure: Shoulder dystocia
timeFrame: During intrapartum admission to Labor & Delivery
measure: Apgar
timeFrame: 5 minutes after birth
measure: Cord gas pH <7.0
timeFrame: Within 24 hours of birth
measure: Base excess
timeFrame: Within 24 hours of birth
measure: Neonatal blood glucose
timeFrame: Within 24 hours of birth
measure: RDS
timeFrame: Within 30 days of delivery
measure: TTN
timeFrame: Within 30 days of delivery
measure: Hyperbilirubinemia
timeFrame: Within 30 days of delivery
measure: Neonatal sepsis
timeFrame: Within 30 days of delivery
measure: NICU
timeFrame: Within 30 days of delivery
measure: Length of stay (neonatal)
timeFrame: From birth until discharge (up to 1 year)
measure: Congenital anomaly
timeFrame: Within 30 days of delivery
measure: IUFD or stillbirth
timeFrame: From conception until delivery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County + University of Southern California Medical Center (LAC+USC)
state: California
Study officials:
References:
citation: Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
citation: ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
citation: ACOG Practice Bulletin No. 190 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):406-408. doi: 10.1097/AOG.0000000000002498.
citation: Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
citation: Hernandez TL. Glycemic targets in pregnancies affected by diabetes: historical perspective and future directions. Curr Diab Rep. 2015 Jan;15(1):565. doi: 10.1007/s11892-014-0565-2.
citation: Fraser R. Diabetic control in pregnancy and intrauterine growth of the fetus. Br J Obstet Gynaecol. 1995 Apr;102(4):275-7. doi: 10.1111/j.1471-0528.1995.tb09130.x. No abstract available.
citation: Dandona P, Besterman HS, Freedman DB, Boag F, Taylor AM, Beckett AG. Macrosomia despite well-controlled diabetic pregnancy. Lancet. 1984 Mar 31;1(8379):737. doi: 10.1016/s0140-6736(84)92248-7. No abstract available.
citation: Combs CA, Gunderson E, Kitzmiller JL, Gavin LA, Main EK. Relationship of fetal macrosomia to maternal postprandial glucose control during pregnancy. Diabetes Care. 1992 Oct;15(10):1251-7. doi: 10.2337/diacare.15.10.1251.
citation: Hernandez TL, Friedman JE, Van Pelt RE, Barbour LA. Patterns of glycemia in normal pregnancy: should the current therapeutic targets be challenged? Diabetes Care. 2011 Jul;34(7):1660-8. doi: 10.2337/dc11-0241. No abstract available.
citation: Thompson DM, Dansereau J, Creed M, Ridell L. Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. Obstet Gynecol. 1994 Mar;83(3):362-6.
citation: Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
citation: Buchanan TA, Kjos SL, Montoro MN, Wu PY, Madrilejo NG, Gonzalez M, Nunez V, Pantoja PM, Xiang A. Use of fetal ultrasound to select metabolic therapy for pregnancies complicated by mild gestational diabetes. Diabetes Care. 1994 Apr;17(4):275-83. doi: 10.2337/diacare.17.4.275.
citation: Kjos SL, Schaefer-Graf U, Sardesi S, Peters RK, Buley A, Xiang AH, Bryne JD, Sutherland C, Montoro MN, Buchanan TA. A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. Diabetes Care. 2001 Nov;24(11):1904-10. doi: 10.2337/diacare.24.11.1904.
citation: American Diabetes Association. 14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S183-S192. doi: 10.2337/dc20-S014.
citation: American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.
citation: American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70. doi: 10.2337/dc19-S006.