Type 2 Diabetes Mellitus (T2DM)PRECIOUSNCT07184775
CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes
A study testing Continuous glucose monitor and Glucometer in people with Type 2 Diabetes Mellitus (T2DM) and Pregnancy, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Pregnancy, Continuous Glucose Monitoring System
- What is being tested?
- Continuous glucose monitor and Glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton pregnancies
- fetuses without anomalies
- diagnosis of Type 2 diabetes
- initiation of prenatal care at <20 weeks gestation
Who cannot join
- diagnosis of Type 1 diabetes
- allergy to insulin
- inability to wear a continuous glucose monitor
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Brandy Firman, 215--955-8401, brandy.firman@jefferson.edu
- Recruiting
Jefferson Health New Jersey
Sewell, New Jersey, 08080
Brandy Firman, 215-955-8401, brandy.firman@jefferson.edu
About this study
Official title: Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements.
Patients involved in the study will be assigned to either:
Read more
- Fingerstick glucose monitoring (FSG)
- Continuous glucose monitoring (CGM)
Patients will be randomize in a 1:1 ratio.
FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery.
CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days.
Percent adherence will be recorded from the time you were randomized to a study group until delivery.
Read the detailed description
About 1-2% of pregnant patients in the United States have pregestational type 2 diabetes (T2DM). The current standard of care for patients needing pharmacotherapy is to initiate basal and postprandial insulin as determined by the patient's reported blood glucose levels after a week of finger-stick glucose monitoring (FSG). This approach is dependent on the patient performing four finger sticks daily and keeping a record of those values. Titration of medication is also dependent on this process. Patient adherence with finger stick glucose testing is reported at about 50%. Continuous glucose monitors (CGMs) allow for continuous collection of blood glucose data without the patient needing to stick themselves or record their values. Increased adherence has been associated with improved maternal and neonatal outcomes. The goal of this randomized control trial is to determine if CGMs have greater adherence compared to FSG.
The investigator's first aim is to compare adherence to glucose monitoring using CGM versus finger stick monitoring in pregnant patients with T2DM. The investigator's second aim is to compare neonatal and maternal outcomes using CGM versus finger stick monitoring in pregnant patients with T2DM. The investigators hypothesize that CGMs will have increased adherence compared to finger stick glucose monitoring. The investigators also hypothesize that CGM will lead to improved glycemic control, improved neonatal outcomes, and improved maternal outcomes compared to finger stick glucose monitoring.
This is a prospective randomized controlled trial (RCT) comparing adherence to CGM versus FSG in patients with pregestational T2DM prior to initiating prenatal care. T2DM will be defined as the American Diabetes Association (ADA) criteria for diagnosis prior to the date of conception. Patients will receive a CGM after diagnosis will target blood glucose ranges between 65-140 mg/dL.
Participants will be screened, consented, and recruited at their initial prenatal visit. They will then be randomized to either the control FSG arm or the intervention CGM arm. Patients with T2DM are seen every 1 to 2 weeks for medication titration and BG checks, and the investigators would continue this workflow, following patients to delivery. If the patient requires insulin uptitration, a weight-based regimen as described by the ADA will be used. Patients will be seen every 1-2 weeks to titrate insulin to meet target ranges. The only difference in management between two groups will be the way the investigators measure blood glucose. Any indications for delivery will be managed in the same manner independent of group assignment based on the institution's clinical guidelines. After delivery, the investigators would review the documented neonatal and maternal outcomes and documented adherence.
The primary outcome is percent adherence, which will be calculated as number of days used with >75% of time coverage divided by the number of days from initiation to delivery for CGM and number of values reported divided by 28 (4 values are intended to be reported daily), divided by weeks from initiation to delivery for FSG. Secondary outcome is a composite of adverse neonatal outcomes, including the following measures: stillbirth, miscarriage, large for gestational age (LGA) of neonate defined as birth weight >90th percentile for gestational age, fetal hypoglycemia defined as glucose <40 mg/dL <48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, or birth trauma. Another secondary outcome is a composite of adverse maternal outcomes, including the following measures: maternal hypoglycemia < 60 mg/dL, shoulder dystocia, OASIS Injuries, operative delivery or c-section, postpartum hemorrhage, or hypertensive disorder of pregnancy.
- Being tested
- Continuous glucose monitor, Glucometer
- Keywords
- Type 2 Diabetes, Diabetes, continuous glucose monitor, CGM, adherence, pregnancy, maternal health, prenatal care, glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Also called CGM
Continuous glucose monitors are sensors that detect interstitial blood glucose measurements and relay values from their sensor to a receiver (typically a cell phone) to document values every 5 minutes.
GlucometerDevice
Glucometer measurement involves a patient performing a finger stick with a lancet to draw blood. They then apply blood to a test strip which is analyzed by a glucometer. The glucose measurement provided by the glucometer is then recorded by the patient in a glucose log.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Active comparator | Patients in this arm of the study will use a continuous glucose monitoring device for glucose monitoring throughout their pregnancy, linked with a HIPAA-compliant digital application that will document measurements. Receives: Device: Continuous glucose monitor |
| Finger stick blood glucose monitoring | Active comparator | Patients randomized to this arm will perform finger stick blood glucose measurements 4x daily (fasting and 2 hours after each meal) and document their measurements in a glucose log. Receives: Device: Glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient glucose monitoring adherence
Compare adherence to glucose monitoring using continuous glucose monitoring versus finger stick monitoring in pregnant patients with Type 2 Diabetes
Measured: through pregnancy episode, typically 20-35 weeks
Secondary outcomes (2)
Fetal/neonatal outcomes
Evaluate differences in fetal/neonatal composite morbidity or mortality between groups, including the following measures: stillbirth, miscarriage, large for gestational age (LGA) of neonate defined as birth weight >90th percentile for gestational age, fetal hypoglycemia defined as glucose <40 mg/dL <48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, or birth trauma.
Measured: through pregnancy episode, typically 20-35 weeks
Maternal outcomes
Determine rates of composite maternal severe morbidity or mortality between groups, including the following measures: maternal hypoglycemia < 60 mg/dL, shoulder dystocia, OASIS Injuries, operative delivery or cesarean section, postpartum hemorrhage, or hypertensive disorder of pregnancy.
Measured: through pregnancy episode, typically 20-35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Responsible party
- Principal investigator, Huda Al-Kouatly, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184775
- Sponsor's protocol ID
- iRISID-2024-1410
- Acronym
- PRECIOUS
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18818254Wernimont SA, Sheng JS, Tymkowicz A, Fleener DK, Summers KM, Syrop CH, Andrews JI. Adherence to self-glucose monitoring recommendations and perinatal outcomes in pregnancies complicated by diabetes mellitus. Am J Obstet Gynecol MFM. 2019 Aug;1(3):100031. doi: 10.1016/j.ajogmf.2019.100031. Epub 2019 Aug 5.
PubMed 33345801
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes
- ClinicalTrials.gov ID
- NCT07184775
- Acronym / sponsor ID
- PRECIOUS / iRISID-2024-1410
- Keywords
- Type 2 Diabetes, Diabetes, continuous glucose monitor, CGM, adherence, pregnancy, maternal health, prenatal care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements.
Patients involved in the study will be assigned to either:
- Fingerstick glucose monitoring (FSG)
- Continuous glucose monitoring (CGM)
Patients will be randomize in a 1:1 ratio.
FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery.
CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days.
Percent adherence will be recorded from the time you were randomized to a study group until delivery.
Detailed description
About 1-2% of pregnant patients in the United States have pregestational type 2 diabetes (T2DM). The current standard of care for patients needing pharmacotherapy is to initiate basal and postprandial insulin as determined by the patient's reported blood glucose levels after a week of finger-stick glucose monitoring (FSG). This approach is dependent on the patient performing four finger sticks daily and keeping a record of those values. Titration of medication is also dependent on this process. Patient adherence with finger stick glucose testing is reported at about 50%. Continuous glucose monitors (CGMs) allow for continuous collection of blood glucose data without the patient needing to stick themselves or record their values. Increased adherence has been associated with improved maternal and neonatal outcomes. The goal of this randomized control trial is to determine if CGMs have greater adherence compared to FSG.
The investigator's first aim is to compare adherence to glucose monitoring using CGM versus finger stick monitoring in pregnant patients with T2DM. The investigator's second aim is to compare neonatal and maternal outcomes using CGM versus finger stick monitoring in pregnant patients with T2DM. The investigators hypothesize that CGMs will have increased adherence compared to finger stick glucose monitoring. The investigators also hypothesize that CGM will lead to improved glycemic control, improved neonatal outcomes, and improved maternal outcomes compared to finger stick glucose monitoring.
This is a prospective randomized controlled trial (RCT) comparing adherence to CGM versus FSG in patients with pregestational T2DM prior to initiating prenatal care. T2DM will be defined as the American Diabetes Association (ADA) criteria for diagnosis prior to the date of conception. Patients will receive a CGM after diagnosis will target blood glucose ranges between 65-140 mg/dL.
Participants will be screened, consented, and recruited at their initial prenatal visit. They will then be randomized to either the control FSG arm or the intervention CGM arm. Patients with T2DM are seen every 1 to 2 weeks for medication titration and BG checks, and the investigators would continue this workflow, following patients to delivery. If the patient requires insulin uptitration, a weight-based regimen as described by the ADA will be used. Patients will be seen every 1-2 weeks to titrate insulin to meet target ranges. The only difference in management between two groups will be the way the investigators measure blood glucose. Any indications for delivery will be managed in the same manner independent of group assignment based on the institution's clinical guidelines. After delivery, the investigators would review the documented neonatal and maternal outcomes and documented adherence.
The primary outcome is percent adherence, which will be calculated as number of days used with >75% of time coverage divided by the number of days from initiation to delivery for CGM and number of values reported divided by 28 (4 values are intended to be reported daily), divided by weeks from initiation to delivery for FSG. Secondary outcome is a composite of adverse neonatal outcomes, including the following measures: stillbirth, miscarriage, large for gestational age (LGA) of neonate defined as birth weight >90th percentile for gestational age, fetal hypoglycemia defined as glucose <40 mg/dL <48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, or birth trauma. Another secondary outcome is a composite of adverse maternal outcomes, including the following measures: maternal hypoglycemia < 60 mg/dL, shoulder dystocia, OASIS Injuries, operative delivery or c-section, postpartum hemorrhage, or hypertensive disorder of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Active comparator | Device: Continuous glucose monitorPatients in this arm of the study will use a continuous glucose monitoring device for glucose monitoring throughout their pregnancy, linked with a HIPAA-compliant digital application that will document measurements. |
| Finger stick blood glucose monitoring | Active comparator | Device: GlucometerPatients randomized to this arm will perform finger stick blood glucose measurements 4x daily (fasting and 2 hours after each meal) and document their measurements in a glucose log. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- singleton pregnancies
- fetuses without anomalies
- diagnosis of Type 2 diabetes
- initiation of prenatal care at <20 weeks gestation
Key exclusion criteria (3 listed)
- diagnosis of Type 1 diabetes
- allergy to insulin
- inability to wear a continuous glucose monitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorAlso: CGMContinuous glucose monitors are sensors that detect interstitial blood glucose measurements and relay values from their sensor to a receiver (typically a cell phone) to document values every 5 minutes. | Device | Continuous glucose monitoring |
| GlucometerGlucometer measurement involves a patient performing a finger stick with a lancet to draw blood. They then apply blood to a test strip which is analyzed by a glucometer. The glucose measurement provided by the glucometer is then recorded by the patient in a glucose log. | Device | Finger stick blood glucose monitoring |
Primary outcome
Patient glucose monitoring adherence
Time frame: through pregnancy episode, typically 20-35 weeks
Compare adherence to glucose monitoring using continuous glucose monitoring versus finger stick monitoring in pregnant patients with Type 2 Diabetes
2 secondary outcomes
Fetal/neonatal outcomes
Time frame: through pregnancy episode, typically 20-35 weeks
Maternal outcomes
Time frame: through pregnancy episode, typically 20-35 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Background: PubMed 18818254Murphy 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.
- Background: PubMed 33345801Wernimont SA, Sheng JS, Tymkowicz A, Fleener DK, Summers KM, Syrop CH, Andrews JI. Adherence to self-glucose monitoring recommendations and perinatal outcomes in pregnancies complicated by diabetes mellitus. Am J Obstet Gynecol MFM. 2019 Aug;1(3):100031. doi: 10.1016/j.ajogmf.2019.100031. Epub 2019 Aug 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor and Glucometer in people with Type 2 Diabetes Mellitus (T2DM) and Pregnancy, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandy Firman (215-955-8401, brandy.firman@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient glucose monitoring adherence (time frame: through pregnancy episode, typically 20-35 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184775, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.