Glycemic Targets for Pregnant Women With GDM and T2DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672031
• Other study ID #: APP-20-06210
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: July 2023

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: Brendan H Grubbs, MD
• Phone: 323-409-3306
• Email: brendan.grubbs[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus in Pregnancy
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pregnancy in Diabetics

Intervention

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.

Locations

Country	Name	City	State
United States	Los Angeles County + University of Southern California Medical Center (LAC+USC)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (16)

ACOG Practice Bulletin No. 190 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):406-408. doi: 10.1097/AOG.0000000000002498. — View Citation

ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. — View 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. Erratum In: Pediatrics. 2004 Oct;114 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in birth weight	250-gram difference in birth weight	41 weeks gestation
Secondary	Total prenatal care visits	Total number of prenatal care visits during pregnancy	41 weeks gestation
Secondary	Prenatal care visits after enrollment	Number of prenatal care visits after enrollment	41 weeks gestation
Secondary	Prenatal care visits: log/glucometer	Number of prenatal care visits with log/glucometer available for RN or MD to review	41 weeks gestation
Secondary	Prenatal care visits: targets met	Number of prenatal care visits in which patient met blood sugar targets	41 weeks gestation
Secondary	Prenatal care visits: intervention	Number of prenatal care visits in which an intervention for blood sugars was recommended (e.g. starting medication or changing medication dose)	41 weeks gestation
Secondary	Symptomatic hypoglycemia	Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)	41 weeks gestation
Secondary	Asymptomatic hypoglycemia	Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)	41 weeks gestation
Secondary	A1c enrollment	Hemoglobin A1c at the time of enrollment	At time of enrollment (up to 34 weeks gestation)
Secondary	A1c 36 weeks	Hemoglobin A1c at 36 weeks gestational age	At 36 weeks gestational age
Secondary	Lowest recorded blood sugar	Lowest recorded blood sugar during prenatal care	41 weeks gestation
Secondary	Highest recorded blood sugar	Highest recorded blood sugar during prenatal care	41 weeks gestation
Secondary	Average recorded blood sugar	Average recorded blood sugar during prenatal care	41 weeks gestation
Secondary	Weekly compliance	Average number of blood sugar checks actually performed each week	41 weeks gestation
Secondary	Weekly target assessment	% of blood sugars within goal each week	41 weeks gestation
Secondary	Diabetes medication	Did the patient need diabetes medication (including oral agents and insulin) during antepartum period?	41 weeks gestation
Secondary	Intrapartum insulin	Did the patient need insulin during the intrapartum period?	From onset of induction/labor until delivery
Secondary	Gestational weight gain	Total weight gain during pregnancy in kilograms	41 weeks gestation
Secondary	Antepartum admission	Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication?	41 weeks gestation
Secondary	Corticosteroids	Did the patient receive antenatal corticosteroid treatment?	41 weeks gestation
Secondary	Oligohydramnios	Amniotic fluid index <5 cm or maximum vertical pocket <2cm	41 weeks gestation
Secondary	Polyhydramnios	Amniotic fluid index >24cm or maximum vertical pocket >8cm	41 weeks gestation
Secondary	Fetal growth restriction	Ultrasonographic estimated fetal weight or abdominal circumference <10% for gestational ag	41 weeks gestation
Secondary	Gestational age at delivery	Gestational age at delivery	During intrapartum admission to Labor & Delivery
Secondary	Induction of labor	Did the patient undergo induction of labor?	During intrapartum admission to Labor & Delivery
Secondary	Mode of delivery	primary cesarean section, repeat cesarean section, vaginal delivery, vaginal delivery with vacuum, vaginal delivery with forceps	During intrapartum admission to Labor & Delivery
Secondary	Cesarean indication	If the patient had cesarean delivery, what was the indication?	During intrapartum admission to Labor & Delivery
Secondary	TOLAC	Did the patient attempt a trial of labor after cesarean?	During intrapartum admission to Labor & Delivery
Secondary	Blood loss	Quantitative blood loss (or estimated if quantitative is unknown) in cc's	During intrapartum admission to Labor & Delivery
Secondary	3rd or 4th degree laceration	3rd or 4th degree perineal laceration	During intrapartum admission to Labor & Delivery
Secondary	PIH	Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome)	From 20 weeks gestation until 30 days postpartum
Secondary	Hypertensive emergency	Did the patient have severe-range blood pressures require antihypertensive medication?	From conception until 30 days postpartum
Secondary	Chorioamnionitis	Chorioamnionitis	During intrapartum admission to Labor & Delivery
Secondary	Endometritis	Endometritis	Within 30 days postpartum
Secondary	VTE	Venous thromboembolism: deep venous thrombosis or pulmonary embolism	From conception until 30 days postpartum
Secondary	Length of stay (maternal)	Length of hospital admission for labor, delivery, and postpartum	From admission to Labor & Delivery until discharge from postpartum
Secondary	Postpartum readmission	Did the patient get readmitted within 30 days of delivery?	Within 30 days postpartum
Secondary	Postpartum wound complication	Cesarean wound infection of dehiscence, perineal laceration breakdown	Within 30 days postpartum
Secondary	Cardiac complications	Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy?	From conception until 30 days postpartum
Secondary	Seizures	Did any maternal seizures occur during the pregnancy or postpartum?	From conception until 30 days postpartum
Secondary	Macrosomia	Birth weight >4000 grams	Within 24 hours of birth
Secondary	LGA	Large for gestational age (birth weight =90% for gestational age)	Within 24 hours of birth
Secondary	SGA	Small for gestational age (birth weight <10% for gestational age)	Within 24 hours of birth
Secondary	Shoulder dystocia	Shoulder dystocia	During intrapartum admission to Labor & Delivery
Secondary	Apgar	5-minute Apgar score	5 minutes after birth
Secondary	Cord gas pH <7.0	Did the baby have a cord blood gas pH <7.0?	Within 24 hours of birth
Secondary	Base excess	What was the base excess on the cord blood gas?	Within 24 hours of birth
Secondary	Neonatal blood glucose	What was the neonatal serum blood glucose at birth?	Within 24 hours of birth
Secondary	RDS	Neonatal respiratory distress syndrome	Within 30 days of delivery
Secondary	TTN	Transient tachypnea of the newborn	Within 30 days of delivery
Secondary	Hyperbilirubinemia	Neonatal hyperbilirubinemia (as defined in AAP 2004 Clinical Practice Guideline "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation")	Within 30 days of delivery
Secondary	Neonatal sepsis	Neonatal sepsis	Within 30 days of delivery
Secondary	NICU	NICU admission	Within 30 days of delivery
Secondary	Length of stay (neonatal)	How many days after birth did the neonate stay in the hospital?	From birth until discharge (up to 1 year)
Secondary	Congenital anomaly	Congenital anomaly	Within 30 days of delivery
Secondary	IUFD or stillbirth	Intrauterine fetal demise or stillbirth	From conception until delivery