Glycemic Targets for Pregnant Women With GDM and T2DM

NCT04672031 | Unknown

• 1 other identifier: APP-20-06210
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus in Pregnancy; Diabetes, Gestational; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Difference in birth weight

  250-gram difference in birth weight

  41 weeks gestation

Secondary Outcomes (55)

• Total prenatal care visits

  41 weeks gestation

• Prenatal care visits after enrollment

  41 weeks gestation

• Prenatal care visits: log/glucometer

  41 weeks gestation

• Prenatal care visits: targets met

  41 weeks gestation

• Prenatal care visits: intervention

  41 weeks gestation

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Interventional Arm

EXPERIMENTAL

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

Interventions

Glycemic Targets OTHER

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County + University of Southern California Medical Center (LAC+USC)

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (16)

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

  PMID: 31856124 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 BACKGROUND

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

  PMID: 29370044 BACKGROUND

• 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.

  PMID: 9704245 BACKGROUND

• 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.

  PMID: 25398204 BACKGROUND

• 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.

  PMID: 7612507 BACKGROUND

• 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.

  PMID: 6143065 BACKGROUND

• 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.

  PMID: 1425084 BACKGROUND

• 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.

  PMID: 21709299 BACKGROUND

• 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.

  PMID: 8127526 BACKGROUND

• 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.

  PMID: 7148898 BACKGROUND

• 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.

  PMID: 8026282 BACKGROUND

• 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.

  PMID: 11679455 BACKGROUND

• 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.

  PMID: 31862757 BACKGROUND

• 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.

  PMID: 15231951 RESULT

• 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.

  PMID: 30559232 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Brendan H Grubbs, MD

CONTACT

323-409-3306; brendan.grubbs@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: July 8, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)