CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes

NCT04219085 | Completed Results DMC FDA Device

• 2 other identifiers: 2000027143000
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.

Conditions

Gestational Diabetes; Maternal Complication of Pregnancy

Keywords

gestational diabetes; fetal or neonatal outcomes; maternal morbidity

Outcome Measures

Primary Outcomes (1)

• Composite Primary Outcome

  The number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.

  from enrollment up until delivery by 41 weeks gestation, up to 19 weeks total

Secondary Outcomes (2)

• Cesarean Delivery for an Arrest of Labor Disorder

  during delivery by 40 weeks gestation

• Hypertensive Disorders of Pregnancy.

  from enrollment, through delivery by 41 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum, up to 20 weeks total

Study Arms (2)

Routine Care

ACTIVE COMPARATOR

Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day

Other: Routine Care

Continuous Glucose Monitor

EXPERIMENTAL

Monitoring of control of gestational diabetes with use of a continuous glucose monitor

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes

Continuous Glucose Monitor

Routine Care OTHER

Use of a glucometer to monitor blood glucose levels in women with gestational diabetes

Routine Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: ongoing pregnancy is required for study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women between 18-50 years old
• pregnant
• singleton gestation
• diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation

You may not qualify if:

• pregestational diabetes
• diagnosis with gestational diabetes \< 24 weeks gestation or \> 36 weeks gestation
• known fetal anomalies
• fetal growth restriction diagnosed during the current pregnancy
• diagnosis of polyhydramnios at time of randomization
• abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization
• twin or higher order multiple gestation
• non-compliance with prenatal visits (missing ≥3 visits prior to enrollment) prior to diagnosis with A2 gestational diabetes
• maternal medical comorbidities including the following: lupus, chronic hypertension, cancer, ischemic cardiovascular disease

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (8)

• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50.

  PMID: 30707672 BACKGROUND

• The American College of Obstetricians and Gynecologists Practice Bulletin Number 190. Gestational Diabetes Mellitus. February 2018.

  BACKGROUND

• Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.

  PMID: 15951574 BACKGROUND

• Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.

  PMID: 19797280 BACKGROUND

• Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.

  PMID: 23712381 BACKGROUND

• Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.

  PMID: 28724718 BACKGROUND

• Law GR, Alnaji A, Alrefaii L, Endersby D, Cartland SJ, Gilbey SG, Jennings PE, Murphy HR, Scott EM. Response to Comment on Law et al. Suboptimal Nocturnal Glucose Control Is Associated With Large for Gestational Age in Treated Gestational Diabetes Mellitus. Diabetes Care 2019;42:810-815. Diabetes Care. 2019 Jul;42(7):e123-e124. doi: 10.2337/dci19-0018. No abstract available.

  PMID: 31221709 BACKGROUND

• Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.

  PMID: 28923465 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

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

Results Point of Contact

• Title: Audrey Merriam
• Organization: Yale University

audrey.merriam@yale.edu

203-785-7813

Study Officials

• Audrey Merriam, MD, MS

  Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial, not blinded

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: September 1, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)