An interventional study of CGM in Type 2 Diabetes Mellitus (T2DM) and Pregnancy, sponsored by University of Alabama at Birmingham. Recruiting at 7 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are:
Participants will:
We will conduct a multicenter, open-label randomized controlled trial of pregnant individuals with T2DM to test the effectiveness of CGM at improving maternal and neonatal outcomes, compared to SMBG. All pregnant women who have T2DM will be screened for eligibility. If a patient is eligible, the study will be explained to them and if they consent to participate, they will be randomized centrally in a 1:1 ratio to CGM or SMBG.
Participants randomized to CGM will receive a Dexcom G7 CGM and be instructed how to apply it, access the CGM data, and how to interpret and respond to trend arrows and alerts. Participants will replace the CGM device with a new sensor every 10 days for the entire pregnancy. Participants randomized to SMBG will be instructed to perform SMBG at least 4 times daily (fasting and 1-hour or 2-hours postprandial) and share their glucose data with their provider according to standard care. In order to collect comparable assessments of glycemic control between the groups, participants randomized to SMBG will wear a masked CGM for 10 days after randomization (Visit 1) and after Visits 2 (24 weeks) and Visit 3 (34 weeks). All participants will be provided a glucometer if they do not already have one and will have HbA1c and maternal serum collected at enrollment (6-22 weeks) and all study visits (24 weeks, 34 weeks, and delivery).
We will utilize ACOG and ADA recommendations for glycemic targets in pregnancy a standardized protocol with graduated goals for glycemic control to ensure consistency across arms and study sites. For pregnant individuals randomized to CGM, the target range will be 63-140mg/dL. For pregnant individuals randomized to SMBG, the targets will be fasting \<95mg/dL, 1-hour postprandial less than 140mg/dL and 2-hour postprandial less than 120mg/dL. CGM reports and glucose logs will be reviewed at least every 1-2 weeks, and therapy adjustments (insulin, metformin, diet and/or lifestyle) will be recommended if less than 70% of glucose values are at target, regardless of the method of glucose monitoring. Additional therapy adjustments will be encouraged to achieve greater than 70% glucose values at target so long as there is not significant hypoglycemia (i.e. greater than 4%).
Telehealth visits may be utilized in addition to outpatient in person visits at the discretion of the provider, but should be used similarly for the CGM and SMBG groups. This protocol for glycemic management will be followed at all times including both at outpatient visits and during inpatient antepartum hospitalization. Intrapartum glycemic control, fetal testing and timing and route of delivery will be determined by the clinical provider in accordance with ACOG recommendations. After birth, umbilical cord blood will be collected for metabolic analyses, and neonates will have a heelstick performed to measure capillary blood glucose as part of usual care given maternal T2DM. Additional care including NICU admission and treatment of hypoglycemia will be at the discretion of the neonatal provider.
Validated screening tools to assess different SDoH domains will be administered at the first 2 study visits. At enrollment, each participant will be administered the Protocol for Responding to and Assessing Patient Assets, Risks and Experiences (PRAPARE) survey, a validated screening tool designed to identify SDoH including personal factors, family and housing, money and resources, and social and emotional health and safety. The home address provided will be used to calculate SVI and area deprivation index (ADI), a measure created to assess socioeconomic disadvantage at a neighborhood level based on income, education, employment and housing quality. Participants will complete the U.S. Adult Household Food Security Survey Module (HFSSM), a 10-item self-report questionnaire aimed at assessing food security over the prior 12 months as food insecurity may be associated with adverse outcomes. Participants will also complete the Type 2 Diabetes Distress Assessment System (T2-DDAS), a 29-item survey designed to identify the overall amount of DM-related distress as well as the sources of stress including hypoglycemia, long-term health, healthcare provider, interpersonal issues, shame or stigma, healthcare access, and management demands. At visit 2, participants will complete the Short Assessment of Health Literacy (SAHL) and the Diabetes Numeracy Test 15 (DNT15) given association between lower educational attainment and health literacy and numeracy with worse outcomes. Participants will also complete the Multidimensional Scale of Perceived Social Support (MSPSS), the only self-reported measure in a study of psychosocial stress associated with adverse pregnancy outcomes and the Experiences of Discrimination (EOD) scale, a 9-item self-report about lifetime experiences of discrimination attributed to race, ethnicity or skin color. At delivery, participants will repeat the T2-DDAS to assess if CGM impacted DM distress and complete a Glucose Monitoring Satisfaction Survey (GMSS), a validated tool to assess satisfaction with the assigned method of glucose monitoring.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 564 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Real-time continuous glucose monitoring
Device: CGM
Self-monitoring of blood glucose (standard of care)
Real-time continuous glucose monitoring
Time in Range (TIR) at 34 weeks gestation
Percentage of time spent within target range (63-140mg/dL) on Continuous Glucose Monitoring at 34 weeks gestation
Time frame: 33 to 35 weeks gestation
Composite Neonatal Morbidity
Composite morbidity of the neonate including one or more of preterm birth (delivery less than 37 weeks for any indication), birth trauma (shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to resolve), hypoglycemia (requiring treatment with dextrose gel or IV within 24 hours of birth), hyperbilirubinemia (requiring phototherapy within 72 hours of birth), large-for-gestational-age infant (birthweight greater than the 90th percentile for gestational age), and miscarriage, stillbirth or neonatal death prior to hospital discharge.
Time frame: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life
Preterm birth
Delivery less than 37 weeks gestation
Time frame: Delivery
Birth trauma
Shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to relieve
Time frame: Delivery
Neonatal hypoglycemia
Low neonatal glucose requiring treatment with dextrose gel or IV within 24 hours of life
Time frame: Delivery to 24 hours of life
Hyperbilirubinemia
Elevated bilirubin requiring phototherapy within 72 hours of life
Time frame: Delivery to 72 hours of life
Large-for-gestational-age (LGA) neonate
Birthweight greater than the 90th percentile for gestational age
Time frame: Delivery
Small-for-gestational-age (SGA) neonate
Birthweight less than the 10th percentile for gestational age
Time frame: Delivery
Fetal glucose
Concentration of umbilical cord blood glucose (mg/dL)
Time frame: Delivery
Fetal insulin
Concentration of umbilical cord blood insulin (uU/mL)
Time frame: Delivery
Fetal C-peptide
Concentration of umbilical cord blood C-peptide (ng/mL)
Time frame: Delivery
Fetal leptin
Concentration of umbilical cord blood leptin (ng/mL)
Time frame: Delivery
Fetal ghrelin
Concentration of umbilical cord blood ghrelin (uU/L)
Time frame: Delivery
Fetal surfactant protein D
Concentration of umbilical cord blood surfactant protein D (ng/mL)
Time frame: Delivery
Time Above Range (TAR) at 34 weeks
Percentage of time spent above range greater than 140mg/dL on Continuous Glucose Monitoring (CGM) at 34 weeks
Time frame: 33 to 35 weeks
Time Below Range (TBR) at 34 weeks
Percentage of time spent below range less than 63mg/dL on Continuous Glucose Monitoring at 34 weeks
Time frame: 33 to 35 weeks
Mean glucose at 34 weeks
Average glucose in mg/dL using Continuous Glucose Monitoring data at 34 weeks
Time frame: 33 to 35 weeks
Glucose Management Indicator (GMI)
Glucose management indicator as an estimate of hemoglobin A1c calculated using mean glucose on CGM at 34 weeks
Time frame: 33 to 35 weeks
Glucose variability at 34 weeks
Coefficient of variation calculated as the mean glucose divided by standard deviation using Continuous Glucose Monitoring data at 34 weeks
Time frame: 33 to 35 weeks
Mean fasting glucose at 34 weeks
Average glucose at 6-7am on Continuous Glucose Monitoring at 34 weeks
Time frame: 33 to 35 weeks
Hemoglobin A1c at Delivery
Hemoglobin A1c (%) at delivery
Time frame: Delivery
Insulin total daily dose at delivery
Total number of units of insulin taken per day at time of delivery
Time frame: Delivery
Cesarean delivery
First cesarean delivery or cesarean delivery after a history of prior cesarean
Time frame: Delivery
Glucose Monitoring Satisfaction
Score on glucose monitoring satisfaction survey at delivery
Time frame: Delivery
Fetal or neonatal death
Miscarriage (pregnancy loss less than 20 weeks), stillbirth (fetal death at 20 weeks or more), or neonatal death (death after birth up to 28 days of life)
Time frame: From the date of randomization to the date of neonatal hospital discharge, assessed up to 12 months of life
Neonatal Intensive Care Unit (NICU) Admission
Admission to the neonatal intensive care unit with length of stay greater than 24 hours
Time frame: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life
Neonatal length of stay
Duration of neonatal hospitalization after delivery
Time frame: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life
Neonatal mechanical ventilation
Neonate requiring intubation and mechanical ventilation for respiratory support
Time frame: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life
Insulin increase during pregnancy
Percentage change in total daily dose of insulin at delivery compared to enrollment
Time frame: From the date of randomization to the date of delivery, assessed up to 9 months
Preeclampsia
Elevated blood pressure greater than 140/90 mmHg after 20 weeks gestation with proteinuria or other severe features by ACOG criteria (may be superimposed on chronic hypertension or not)
Time frame: From the date of randomization to the date of maternal hospital discharge after delivery, assessed up to 9 months
Postpartum infection
Developing one or more of endometritis, wound infection or other wound complication such as seroma, hematoma or dehiscence)
Time frame: From the date of delivery through 6 weeks' postpartum
Glucose Monitoring Adherence
Defined as percentage of expected self-monitoring of blood glucose (SMBG) values completed based on recommended 4 values per day for participants in the SMBG arm and percentage of time Continuous Glucose Monitoring (CGM) in use in the CGM arm
Time frame: From the date of randomization to the date of delivery, assessed up to 9 months
Plan to share: Yes — All data produced in the course of the project will be preserved and shared including: 1. Recruitment rates, reasons for refusal, adherence, loss to follow up 2. Demographics and clinical data 3. Glucose and laboratory values 4. Satisfaction and survey responses
Supporting information: Study protocol
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University of Alabama at Birmingham