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The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.
A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.
The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Experimental | Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery. |
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| Fingerstick Glucose Monitoring | Active Comparator | Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | Continuous Glucose Monitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Large for Gestational Age Infant | The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery. | Within 2 hours of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Third Trimester Hemoglobin A1c | Third Trimester Hemoglobin A1c | Between 28 weeks and delivery |
| Mode of Delivery | Mode of delivery (vaginal versus cesarean) |
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Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:
Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianna L Wilkie, MD | Contact | 7743642523 | Gianna.Wilkie@umassmemorial.org | |
| Heidi Leftwich, DO | Contact | Heidi.Leftwich@umassmemorial.org |
| Name | Affiliation | Role |
|---|---|---|
| Gianna L Wilkie, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28923465 | 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. | |
| 29603547 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a prospective, single center, randomized study evaluating pregnancy glycemic monitoring strategies between women with continuous glucose monitors and standard of care fingerstick glucose monitoring.
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| Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) |
| Device |
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) |
|
| At delivery |
| Hypertensive Disorders of Pregnancy | Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation | After 20 weeks of gestation until delivery |
| Preterm Birth | Preterm birth (delivery less than 37 weeks gestation) | At delivery |
| Number of participants with a shoulder dystocia | Number of participants with a shoulder dystocia | At delivery |
| Neonatal Intensive Care Unit Admission (NICU) | Neonatal Intensive Care Unit Admission (NICU) | At delivery and within first 2 days of life |
| Neonatal Respiratory Distress | Neonatal Respiratory Distress requiring respiratory support | At delivery |
| APGAR less than 7 at 5 minutes of life | APGAR score less than 7 at 5 minutes of life | 5 Minutes after Delivery |
| Number of participants with neonatal hypoglycemia | Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth | Within 2 hours of birth |
| Gestational age at delivery | Gestational age at delivery | At Delivery |
| Maternal Patient Satisfaction Survey with Glucose Monitoring | This will be assessed by the glucose monitoring satisfaction survey (GMSS) version 2. Participants will complete the survey, which contains 4 subscales and a total score. The subscales assess openness, emotional burden, behavioral burden, and worthwhileness. The higher the score the greater the satisfaction, with a total maximum score 75. | postpartum day 1 after delivery |
| Background |
| Voormolen DN, DeVries JH, Sanson RME, Heringa MP, de Valk HW, Kok M, van Loon AJ, Hoogenberg K, Bekedam DJ, Brouwer TCB, Porath M, Erdtsieck RJ, NijBijvank B, Kip H, van der Heijden OWH, Elving LD, Hermsen BB, Potter van Loon BJ, Rijnders RJP, Jansen HJ, Langenveld J, Akerboom BMC, Kiewiet RM, Naaktgeboren CA, Mol BWJ, Franx A, Evers IM. Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1894-1902. doi: 10.1111/dom.13310. Epub 2018 May 8. |
| 23349548 | Background | Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24. |
| 18818254 | Background | Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680. |
| D004700 | Endocrine System Diseases |