Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM), Pregnancy, Continuous Glucose Monitoring System
Sponsor: Thomas Jefferson University

 
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Title: Maternal continuous glucose monitoring surveillance compared to finger-stick 
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glucose monitoring in pregnancies with type 2 pregestational diabetes 
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NCT Number: not yet assigned 
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Document Date: 9/10/25 
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RESEARCH PROTOCOL TEMPLATE 
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INVESTIGATOR INITIATED TREATMENT TRIALS 
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Title of Project: Maternal continuous glucose monitoring surveillance compared to 
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finger-stick glucose monitoring in pregnancies with type 2 pregestational diabetes 
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Principal Investigator: 
Rodney McLaren; MD; Department of OBGYN   
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Co-Investigators:  
Rupsa Boelig; MD; Department of OBGYN   
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Kavisha Khanuja; MD; Department of OBGYN   
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Dante Varotsis; MD; Department of OBGYN   
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Anne Bocage; MD; Department of OBGYN   
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Mymy Nguyen; MD; Department of OBGYN   
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Jordan Beacham; BS; Sidney Kimmel Medical College 
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Abstract 
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About 1-2% of pregnant patients in the United States have pregestational type 2 
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diabetes (T2DM). The current standard of care for patients needing pharmacotherapy is 
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to initiate basal and postprandial insulin as determined by patient’s reported blood 
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glucose levels after a week of finger-stick glucose monitoring (FSG). This approach is 
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dependent on the patient performing four finger sticks daily and keeping a record of 
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those values. Titration of medication is also dependent on this process. Patient 
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adherence is reported at 50%. Continuous glucose monitors (CGMs) allow for 
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continuous collection of blood glucose data without the patient needing to stick 
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themselves or record their values. The goal of this randomized control trial is to 
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determine if CGMs have greater adherence compared to FSG. 
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A. Specific Aims 
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Our first aim is to compare adherence to glucose monitoring using CGM vs. finger stick 
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monitoring in pregnant patients with T2DM. Our second aim is to compare neonatal and 
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maternal outcomes using CGM vs. finger stick monitoring in pregnant patients with 
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T2DM. We hypothesize that CGMs will have increased adherence compared to finger 
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stick glucose monitoring. We also hypothesize that CGM will lead to improved glycemic 
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control, improved neonatal outcomes, and improved maternal outcomes compared to 
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finger stick glucose monitoring 
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B.  Background and Significance 
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Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample 
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nutrition. However, in patients where insulin resistance already exists, e.g., patients with 
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T2DM, they have higher risks of pregnancy complications. They are at risk of having 
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larger neonates, neonates with low sugar levels in the first 24 hours of life, higher rates 
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of cesarean delivery, stillbirth, and hypertensive or high blood pressure disorders of 
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pregnancy, such as preeclampsia1,2. Prior studies have demonstrated that treating 
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elevated blood glucose can reduce these risks. However, patient adherence to FSG is 
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reported at 50%3. There are no studies published on adherence to CGMs among 
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patients with T2DM.  
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C.  Preliminary Studies/Progress Report   
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The CONCEPTT trial demonstrated that continuous glucose monitoring (CGM) use in 
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pregnancy for type 1 diabetics (T1DM) was associated with improved neonatal 
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outcomes when compared to FSG4. However, for T2DM, there are minimal evidence of 
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CGM use in this population. There have been no large clinical trials evaluating CGM 
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use among T2DM. The current published literature is underpowered, and contradictory. 
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Murphy, et al. showed improved glycemic control, reduced birthweight and reduced 
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macrosomia5, while Secher, et al. and Voormolen, et al. showed no difference6,7. Thus, 
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there remains a dearth of literature to assess the utility of this glucose monitoring 
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modality in T2DM. 
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D.  Research Design and Methods 
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This is a prospective randomized controlled trial (RCT) comparing the rate of adverse 
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neonatal and maternal outcomes between groups comparing CGM vs. FSG in patients 
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with pregestational T2DM prior to initiating prenatal care. T2DM will be defined as the 
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American Diabetes Association (ADA) criteria for diagnosis prior to the date of 
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conception. Patients will receive a CGM after diagnosis will target blood glucose ranges 
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between 65-140 mg/dL. Participants will be recruited at their initial prenatal visit for 
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T2DM.  
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Participants will be screened, consented, and recruited at their initial prenatal visit. They 
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will then be randomized to either the control FSG arm or the intervention CGM arm. 
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Patients with T2DM are seen every 1 to 2 weeks for medication titration and BG checks, 
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and we would continue this workflow, following patients to delivery. If the patient 
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requires insulin uptitration, a weight-based regimen as described by the ADA will be 
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used. Patients will be seen every 1-2 weeks to titrate insulin to meet target ranges.  
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Percent adherence will be recorded in the medical record, which will be ear tagged in 
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pinky sticky on EPIC by research personnel after enrollment and these patients will be 
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seen by the same providers throughout their pregnancy. The only difference in 
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management between two groups will be the way we measure blood glucose. Any 
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indications for delivery will be managed in the same manner independent of group 
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assignment based on the institution’s clinical guidelines. After delivery, we would review 
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the documented neonatal and maternal outcomes and documented adherence. Please 
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see Figure 1 below for workflow. 
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The primary outcome is percent adherence, which will be calculated as number of days 
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used with >75% of time coverage divided by the number of days from initiation to 
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delivery for CGM and number of values reported divided by 28 (4 values are intended to 
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be reported daily), divided by weeks from initiation to delivery for FSG. Secondary 
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outcome is a composite of adverse neonatal outcomes, including the following 
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measures: stillbirth, miscarriage, large for gestational age (LGA) of neonate defined as 
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birth weight >90th percentile for gestational age, fetal hypoglycemia defined as glucose 
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<40 mg/dL <48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal 
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death, or birth trauma. Another secondary outcome is a composite of adverse maternal 
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outcomes, including the following measures: maternal hypoglycemia < 60 mg/dL, 
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shoulder dystocia, OASIS Injuries, operative delivery or c-section, postpartum 
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hemorrhage, or hypertensive disorder of pregnancy. 
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Figure 1. Study workflow 
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E.  Statistical Methods   
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We will compare the percent adherence between the finger stick glucose and the 
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continuous glucose monitoring group. We will need to recruit 70 patients to achieve a 
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power of 0.80 for an effect size of 0.5 and alpha level of 0.05, anticipating 80% 
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enrollment and 10% attrition from the study. Descriptive statistics will be performed to 
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summarize continuous and categorical data. Continuous data will be tested for 
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normality. Student’s t test will be used to compare continuous data between groups if 
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the data is normal and Wilcoxon rank sum test will be used to compare continuous data 
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that is not normally distributed. Fisher exact test will be used to compare categorical 
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data. Intention to treat analysis will be used for the primary outcome. 
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F.  Gender/Minority/Pediatric Inclusion for Research 
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There will be no effort to recruit any particular racial or ethnic group.  We expect our 
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study population to reflect the patient population at large. Economically disadvantaged 
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persons will be eligible to participate.  Funding is provided in the study budget to pay for 
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any needed medical evaluations for screening, for any patient who is not insured or has 
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limited insurance coverage.  Financial incentives for participation are reasonable to 
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compensate for time, but not so large as to represent a coercive inducement to 
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participation. Students and employees will be able to participate if referred via usual 
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channels.  No student or employee will be pressured to participate.  Any student or 
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employee wishing to participate will be explicitly told that a decision not to participate 
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will in no way affect their educational or employment status. 
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G.  Human Subjects 
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There will be a total of 70 patients needed for the trial. Inclusion criteria include patients 
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>18 years of age, singleton pregnancies, fetuses without anomalies, diagnosis of Type 
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2 diabetes, initiation of prenatal care at <20 weeks gestation. Among those meeting 
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inclusion criteria, patients will be excluded for Type 1 diabetes, allergy to insulin, and 
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inability to wear CGM. Research materials will be acquired in the form of patient data 
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recorded in electronic medical records. Patients will be recruited and consented at their 
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prenatal visit. Continuous glucose monitors are well-validated as alternatives to finger-
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stick glucose and have passed safety measures for their approval for use in diabetic 
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patients by the FDA. The direct benefit that can be achieved by the continuous glucose 
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monitor is increased adherence, and therefore improved insulin titration for the pregnant 
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patient. Potential risks include subject difficulty in using the continuous glucose monitor 
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(low likelihood). 
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H.  Data and Safety Monitoring Plan   
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This protocol poses minimal risk. Only study investigators and personnel will have 
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access to secure RedCAP database linking patient identifier with study ID.  Due to the  
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need to follow pregnancy outcome, it will be necessary to collect identifiable information  
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such as name, date of birth, and medical record number.  This information will be  
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maintained on a separate secure RedCAP database linking patient identifiers with study  
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IDs. 
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I.  Literature Cited 
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1. 
Alexopoulos AS, Blair R, Peters AL. Management of Preexisting Diabetes in Pregnancy: A Review. JAMA. 2019 May 
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14;321(18):1811-1819. doi: 10.1001/jama.2019.4981. PMID: 31087027; PMCID: PMC6657017. 
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2. 
Malaza N, Masete M, Adam S, Dias S, Nyawo T, Pheiffer C. A Systematic Review to Compare Adverse Pregnancy 
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Outcomes in Women with Pregestational Diabetes and Gestational Diabetes. Int J Environ Res Public Health. 2022 Aug 
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31;19(17):10846. doi: 10.3390/ijerph191710846. PMID: 36078559; PMCID: PMC9517767. 
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3. 
Wernimont SA, Sheng JS, Tymkowicz A, Fleener DK, Summers KM, Syrop CH, Andrews JI. Adherence to self-glucose 
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monitoring recommendations and perinatal outcomes in pregnancies complicated by diabetes mellitus. Am J Obstet 
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Gynecol MFM. 2019 Aug;1(3):100031. doi: 10.1016/j.ajogmf.2019.100031. Epub 2019 Aug 5. PMID: 33345801; PMCID: 
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PMC9797350. 
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4. 
Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod 
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M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, 
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Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 
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1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-
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2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. Erratum in: Lancet. 2017 Nov 25;390(10110):2346. doi: 
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10.1016/S0140-6736(17)32712-5. PMID: 28923465; PMCID: PMC5713979. 
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5. 
Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of 
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continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. 
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doi: 10.1136/bmj.a1680. PMID: 18818254; PMCID: PMC2563261. 
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6. 
Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in 
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pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-
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2360. Epub 2013 Jan 24. PMID: 23349548; PMCID: PMC3687305. 
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7. 
Voormolen DN, DeVries JH, Sanson RME, Heringa MP, de Valk HW, Kok M, van Loon AJ, Hoogenberg K, Bekedam DJ, 
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Brouwer TCB, Porath M, Erdtsieck RJ, NijBijvank B, Kip H, van der Heijden OWH, Elving LD, Hermsen BB, Potter van 
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Loon BJ, Rijnders RJP, Jansen HJ, Langenveld J, Akerboom BMC, Kiewiet RM, Naaktgeboren CA, Mol BWJ, Franx A, 
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Evers IM. Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled 
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trial. Diabetes Obes Metab. 2018 Aug;20(8):1894-1902. doi: 10.1111/dom.13310. Epub 2018 May 8. PMID: 29603547. 
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Date 1/12/2025 
 
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Version 1.1  
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Research Protocol Template, 11/15/2010 
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