Type 2 Diabetes Treated With InsulinNCT05317585
Continuous Glucose Monitor Use in Pregnancy
A study testing Continuous Glucose Monitor and Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) in people with Type 2 Diabetes Treated With Insulin and Pregnancy, High Risk, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk
- What is being tested?
- Continuous Glucose Monitor and Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to 1 Jul 2027
- 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
Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:
- 1) age greater than or equal to 18 years old
- 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit
- 3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
- 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
- 5) able and willing to provide informed consent
Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:
- 1) known diagnosis of type 1 diabetes or gestational diabetes
- 2) plan to receive prenatal care or delivery outside of UMMHC
- 3) inability to provide informed consent
- 4) multifetal gestation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Heidi Leftwich, DO contact
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Gianna L Wilkie, MD, 508-334-4067, Gianna.Wilkie@umassmemorial.org
About this study
Official title: Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Continuous Glucose Monitor, Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
- Keywords
- Type 2 diabetes, Pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Continuous Glucose Monitor
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)Device
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Glucose Monitor |
| 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. Receives: Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 hours of birth
Secondary outcomes (11)
Third Trimester Hemoglobin A1c
Third Trimester Hemoglobin A1c
Measured: Between 28 weeks and delivery
Mode of Delivery
Mode of delivery (vaginal versus cesarean)
Measured: At delivery
Hypertensive Disorders of Pregnancy
Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation
Measured: After 20 weeks of gestation until delivery
Preterm Birth
Preterm birth (delivery less than 37 weeks gestation)
Measured: At delivery
Number of participants with a shoulder dystocia
Number of participants with a shoulder dystocia
Measured: At delivery
Neonatal Intensive Care Unit Admission (NICU)
Neonatal Intensive Care Unit Admission (NICU)
Measured: At delivery and within first 2 days of life
Neonatal Respiratory Distress
Neonatal Respiratory Distress requiring respiratory support
Measured: At delivery
APGAR less than 7 at 5 minutes of life
APGAR score less than 7 at 5 minutes of life
Measured: 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
Measured: Within 2 hours of birth
Gestational age at delivery
Gestational age at delivery
Measured: 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.
Measured: postpartum day 1 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start23 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianna Wilkie, University of Massachusetts, Worcester
- Investigators
- Gianna L Wilkie, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317585
- Sponsor's protocol ID
- STUDY00001802
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28923465Voormolen 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.
PubMed 29603547Secher 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.
PubMed 23349548Murphy 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 18818254
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05317585
- Acronym / sponsor ID
- STUDY00001802
- Keywords
- Type 2 diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Apr 2022 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring (CGM) | Experimental | Device: Continuous Glucose MonitorPatients 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. |
| Fingerstick Glucose Monitoring | Active comparator | Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 MonitorContinuous Glucose Monitor | Device | Continuous Glucose Monitoring (CGM) |
| Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) | Device | Fingerstick Glucose Monitoring |
Primary outcome
Large for Gestational Age Infant
Time frame: Within 2 hours of birth
The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.
11 secondary outcomes
Third Trimester Hemoglobin A1c
Time frame: Between 28 weeks and delivery
Mode of Delivery
Time frame: At delivery
Hypertensive Disorders of Pregnancy
Time frame: After 20 weeks of gestation until delivery
Preterm Birth
Time frame: At delivery
Number of participants with a shoulder dystocia
Time frame: At delivery
Neonatal Intensive Care Unit Admission (NICU)
Time frame: At delivery and within first 2 days of life
Neonatal Respiratory Distress
Time frame: At delivery
APGAR less than 7 at 5 minutes of life
Time frame: 5 Minutes after Delivery
Number of participants with neonatal hypoglycemia
Time frame: Within 2 hours of birth
Gestational age at delivery
Time frame: At Delivery
Maternal Patient Satisfaction Survey with Glucose Monitoring
Time frame: postpartum day 1 after delivery
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 3 Aug 2026.
- Background: PubMed 28923465Feig 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.
- Background: PubMed 29603547Voormolen 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.
- Background: PubMed 23349548Secher 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.
- 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.
- 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.
Heidi Leftwich, DO contact
Gianna L Wilkie, MD principal investigator
University of Massachusetts, Worcester
1 site 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 Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) in people with Type 2 Diabetes Treated With Insulin and Pregnancy, High Risk, run by University of Massachusetts, Worcester at 1 site 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?
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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Gianna L Wilkie, MD (7743642523, Gianna.Wilkie@umassmemorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large for Gestational Age Infant (time frame: Within 2 hours of birth). 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 NCT05317585, which also lists 4 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 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.