Gestational DiabetesNCT03326232
Real-time Continuous Glucose Monitoring
A study testing Continuous glucose monitoring in people with Gestational Diabetes, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- maternal age 18 to 45
- singleton gestation
- gestational age less than 32 weeks gestation at study inclusion
- BMI less than 45
- 50g glucose challenge greater than 135 mg/dL
- 100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
- attended the maternal-fetal medicine diabetes education class
Who cannot join
- maternal age less than18 or greater than 45
- multifetal gestation
- gestational age greater than 32 weeks study inclusion
- BMI greater than 45
- pregestational diabetes
- gestational diabetes diagnosed before 24 weeks
Show all 14Show fewer
- did not attend the diabetes education class
- known fetal anomaly
- known fetal aneuploidy
- required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
- learning disability
- concern for non compliance with medical care
- imminent preterm delivery due to maternal disease or fetal conditions
- is not willing to wear CGM
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Joanne Audouin, MS, 757-446-5121, audouij@evms.edu
Andrew Lane, MD, 864-608-4134, laneas@evms.edu
About this study
Official title: Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes. GDM places the pregnancy at great risk to both the mother and the neonate. Recent studies have proven that interventions including dietary and medications lower the risk to the pregnancy. Both the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment of choice. Meanwhile, outside of pregnancy, promising new technologies such as continuous glucose monitors (CGM) are revolutionizing diabetic care. The investigators seek to determine if the constant feedback of a real-time CGM system would improve glycemic control compared to traditional management in GDM
Read the detailed description
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM. First, most studies only use CGM for 48 - 72hours at a time, while the investigators will be using CGM for 7 day intervals. Both groups will use the same Enlite sensor (Medtronic). The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter). The real-time CGM group will be using the 530g system (iPro2 (Enlite sensor + transmitter) + inactivated 530g pump set only to display glucose values, no insulin will be administered). This CGM system has been FDA approved to for up to 7 days between sensor changes.26,27 Second, no previous study has used real time CGM in pregnant patients with GDM in the US. The investigators will be the first to describe the use of this technology in this patient population. Third, most of these trials have been performed on populations that are not representative of the investigators' patient population at EVMS. This will be the largest US study of CGM in GDM. Fourth wearable medical and fitness technology is already popular, but as both the technology and the demand continues to grow, it will become the future of diabetes management. Studies have already shown that real time CGM is an effective educational and motivational tool in type-1 and type-2 DM.28,29
- Conditions
- Gestational Diabetes
- Being tested
- Continuous glucose monitoring
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
| Study group | Role | What they receive |
|---|---|---|
| Blinded continuous glucose monitoring | Experimental | The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). Receives: Device: Continuous glucose monitoring |
| Real time continuous glucose monitoring | Experimental | The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood glucose (mg/dL)
Mean blood glucose (mg/dL) in the real-time CGM group compared to self-monitoring of blood glucose (SMBG) group during the 4th week of study from data collected on the 6 day of CGM use during that week.
Measured: week 1 vs. week 4
Secondary outcomes (22)
Failed dietary therapy
Failed dietary therapy (started on medication),
Measured: week 1 vs. week 4
Time spent in normoglycemia
Time spent in normoglycemia (min/day)
Measured: week 1 vs. week 4
Time spent in hypoglycemia
Time spent in hypoglycemia (min/day)
Measured: week 1 vs. week 4
BMI at time of delivery
BMI at time of delivery (kg/m2)
Measured: BMI at time of delivery
Gestational hypertension
Gestational hypertension (defined as systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mmg Hg, on 2 occasions at least 4 hrs apart
Measured: enrollement vs delivery.
Preeclampsia
Preeclampsia (defined as gestational hypertension plus either new-onset proteinuria (> 300 mg/24 2hrs, protein:creatinine > 0.3 mg/dL), thrombocytopenia (platelet count < 100,000/uL), elevated Aspartate aminotransferase or alanine aminotransferase (> 2x upper limit of normal), renal insufficiency (serum creatinine > 1.1 mg/dL or an unexplained doubling of creatinine), pulmonary edema, or cerebral or visual symptoms
Measured: enrollement vs delivery.
HbA1C values
HbA1C values (%)
Measured: HbA1C values week 1 compared to week 4 (%)
Polyhydramnios
Polyhydramnios (MVP > 8 cm at any point in the pregnancy)
Measured: Through study completion, an average of 9 months
Cesarean delivery
Cesarean delivery (w/ indication: macrosomia, malpresentation, failed induction, fetal distress, failed trial of labor after cesarean, scheduled repeat, other)
Measured: Delivery
Induction of labor
Induction of labor (w/ indication)
Measured: Delivery
Operative vaginal delivery
Operative vaginal delivery (yes/no) and type (forceps/vacuum)
Measured: Delivery
Shoulder dystocia
Shoulder dystocia (diagnosed clinically)
Measured: Delivery
Fetal macrosomia
Fetal macrosomia (> 4,000g at 38 wk u/s)
Measured: Most recent ultrasound before delivery
3rd or 4th degree perineal laceration
3rd or 4th degree perineal laceration at time of delivery
Measured: Delivery
Gestational age at delivery
Gestational age at delivery (weeks, days)
Measured: Delivery
Preterm delivery
Preterm delivery (< 37 weeks gestational age at birth)
Measured: Delivery
Birth weight
Birth weight (grams)
Measured: Delivery
Perinatal morbidity composite outcome
- Hypoglycemia (yes/no): < 2 hrs after birth and before feeding, defined as < 35mg/dL
- Hyperbilirubinemia (yes/no): collected 16-36 hrs after birth, defined as > 95% for any given point after birth requiring phototherapy according to American Academy of Pediatrics guidelines
- Birth trauma (yes/no): brachial plexus injury or clavicular, humeral, or skull fracture
- Intrauterine fetal demise or neonatal death (yes/no): prior to hospital discharge
Measured: Delivery
Large for gestational age
Large for gestational age (yes/no): defined as birth weight > 90%
Measured: Delivery
Small for gestational age
Small for gestational age (yes/no): defined as birth weight < 10%
Measured: Delivery
Admission to neonatal intensive care unit
Admission to neonatal intensive care unit (yes/no) and length of neonatal intensive care unit stay (days)
Measured: Delivery
Respiratory distress syndrome
Respiratory distress syndrome (defined as need to supplemental oxygen > 4 hrs after birth)
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start13 Nov 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Malgorzata Mlynarczyk, MD, PhD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326232
- Sponsor's protocol ID
- 17-07-FB-0181
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Do not plan to share.
Publications
Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013 Aug;122(2 Pt 1):406-416. doi: 10.1097/01.AOG.0000433006.09219.f1.
PubMed 23969827Moyer VA; U.S. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 18;160(6):414-20. doi: 10.7326/M13-2905.
PubMed 24424622Correa A, Bardenheier B, Elixhauser A, Geiss LS, Gregg E. Trends in prevalence of diabetes among delivery hospitalizations, United States, 1993-2009. Matern Child Health J. 2015 Mar;19(3):635-42. doi: 10.1007/s10995-014-1553-5.
PubMed 24996952England LJ, Dietz PM, Njoroge T, Callaghan WM, Bruce C, Buus RM, Williamson DF. Preventing type 2 diabetes: public health implications for women with a history of gestational diabetes mellitus. Am J Obstet Gynecol. 2009 Apr;200(4):365.e1-8. doi: 10.1016/j.ajog.2008.06.031. Epub 2008 Aug 8.
PubMed 18691691Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.
PubMed 15741354Malcolm JC, Lawson ML, Gaboury I, Lough G, Keely E. Glucose tolerance of offspring of mother with gestational diabetes mellitus in a low-risk population. Diabet Med. 2006 May;23(5):565-70. doi: 10.1111/j.1464-5491.2006.01840.x.
PubMed 16681566Gillman MW, Rifas-Shiman S, Berkey CS, Field AE, Colditz GA. Maternal gestational diabetes, birth weight, and adolescent obesity. Pediatrics. 2003 Mar;111(3):e221-6. doi: 10.1542/peds.111.3.e221.
PubMed 12612275HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
PubMed 15951574Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
PubMed 19797280Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
PubMed 23712381Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.
PubMed 15855600Mastrototaro J, Shin J, Marcus A, Sulur G; STAR 1 Clinical Trial Investigators. The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):385-90. doi: 10.1089/dia.2007.0291.
PubMed 18715215Kestila KK, Ekblad UU, Ronnemaa T. Continuous glucose monitoring versus self-monitoring of blood glucose in the treatment of gestational diabetes mellitus. Diabetes Res Clin Pract. 2007 Aug;77(2):174-9. doi: 10.1016/j.diabres.2006.12.012. Epub 2007 Jan 16.
PubMed 17234297Murphy 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 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03326232
- Acronym / sponsor ID
- 17-07-FB-0181
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 31 Oct 2017 (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.
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes. GDM places the pregnancy at great risk to both the mother and the neonate. Recent studies have proven that interventions including dietary and medications lower the risk to the pregnancy. Both the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment of choice. Meanwhile, outside of pregnancy, promising new technologies such as continuous glucose monitors (CGM) are revolutionizing diabetic care. The investigators seek to determine if the constant feedback of a real-time CGM system would improve glycemic control compared to traditional management in GDM
Detailed description
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM. First, most studies only use CGM for 48 - 72hours at a time, while the investigators will be using CGM for 7 day intervals. Both groups will use the same Enlite sensor (Medtronic). The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter). The real-time CGM group will be using the 530g system (iPro2 (Enlite sensor + transmitter) + inactivated 530g pump set only to display glucose values, no insulin will be administered). This CGM system has been FDA approved to for up to 7 days between sensor changes.26,27 Second, no previous study has used real time CGM in pregnant patients with GDM in the US. The investigators will be the first to describe the use of this technology in this patient population. Third, most of these trials have been performed on populations that are not representative of the investigators' patient population at EVMS. This will be the largest US study of CGM in GDM. Fourth wearable medical and fitness technology is already popular, but as both the technology and the demand continues to grow, it will become the future of diabetes management. Studies have already shown that real time CGM is an effective educational and motivational tool in type-1 and type-2 DM.28,29
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded continuous glucose monitoring | Experimental | Device: Continuous glucose monitoringThe blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). |
| Real time continuous glucose monitoring | Experimental | Device: Continuous glucose monitoringThe real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- maternal age 18 to 45
- singleton gestation
- gestational age less than 32 weeks gestation at study inclusion
- BMI less than 45
- 50g glucose challenge greater than 135 mg/dL
Key exclusion criteria (14 listed)
- maternal age less than18 or greater than 45
- multifetal gestation
- gestational age greater than 32 weeks study inclusion
- BMI greater than 45
- pregestational diabetes
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 monitoringThe blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) | Device | Blinded continuous glucose monitoring, Real time continuous glucose monitoring |
Primary outcome
Mean blood glucose (mg/dL)
Time frame: week 1 vs. week 4
Mean blood glucose (mg/dL) in the real-time CGM group compared to self-monitoring of blood glucose (SMBG) group during the 4th week of study from data collected on the 6 day of CGM use during that week.
22 secondary outcomes
Failed dietary therapy
Time frame: week 1 vs. week 4
Time spent in normoglycemia
Time frame: week 1 vs. week 4
Time spent in hypoglycemia
Time frame: week 1 vs. week 4
BMI at time of delivery
Time frame: BMI at time of delivery
Gestational hypertension
Time frame: enrollement vs delivery.
Preeclampsia
Time frame: enrollement vs delivery.
HbA1C values
Time frame: HbA1C values week 1 compared to week 4 (%)
Polyhydramnios
Time frame: Through study completion, an average of 9 months
Cesarean delivery
Time frame: Delivery
Induction of labor
Time frame: Delivery
Operative vaginal delivery
Time frame: Delivery
Shoulder dystocia
Time frame: Delivery
Fetal macrosomia
Time frame: Most recent ultrasound before delivery
3rd or 4th degree perineal laceration
Time frame: Delivery
Gestational age at delivery
Time frame: Delivery
Preterm delivery
Time frame: Delivery
Birth weight
Time frame: Delivery
Perinatal morbidity composite outcome
Time frame: Delivery
Large for gestational age
Time frame: Delivery
Small for gestational age
Time frame: Delivery
Admission to neonatal intensive care unit
Time frame: Delivery
Respiratory distress syndrome
Time frame: Delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Background: PubMed 23969827Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013 Aug;122(2 Pt 1):406-416. doi: 10.1097/01.AOG.0000433006.09219.f1.
- Background: PubMed 24424622Moyer VA; U.S. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 18;160(6):414-20. doi: 10.7326/M13-2905.
- Background: PubMed 24996952Correa A, Bardenheier B, Elixhauser A, Geiss LS, Gregg E. Trends in prevalence of diabetes among delivery hospitalizations, United States, 1993-2009. Matern Child Health J. 2015 Mar;19(3):635-42. doi: 10.1007/s10995-014-1553-5.
- Background: PubMed 18691691England LJ, Dietz PM, Njoroge T, Callaghan WM, Bruce C, Buus RM, Williamson DF. Preventing type 2 diabetes: public health implications for women with a history of gestational diabetes mellitus. Am J Obstet Gynecol. 2009 Apr;200(4):365.e1-8. doi: 10.1016/j.ajog.2008.06.031. Epub 2008 Aug 8.
- Background: PubMed 15741354Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.
- Background: PubMed 16681566Malcolm JC, Lawson ML, Gaboury I, Lough G, Keely E. Glucose tolerance of offspring of mother with gestational diabetes mellitus in a low-risk population. Diabet Med. 2006 May;23(5):565-70. doi: 10.1111/j.1464-5491.2006.01840.x.
- Background: PubMed 12612275Gillman MW, Rifas-Shiman S, Berkey CS, Field AE, Colditz GA. Maternal gestational diabetes, birth weight, and adolescent obesity. Pediatrics. 2003 Mar;111(3):e221-6. doi: 10.1542/peds.111.3.e221.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 15951574Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Background: PubMed 19797280Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
- Background: PubMed 23712381Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
- Background: PubMed 15855600Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.
- Individual participant dataSharing planned: No. Do not plan to share.
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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. This study is not recruiting at the moment.
Malgorzata Mlynarczyk, MD, PhD principal investigator
Eastern Virginia Medical School
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 monitoring in people with Gestational Diabetes, run by Eastern Virginia Medical School 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?
The sponsor lists 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne Audouin, MS (757-446-5121, audouij@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood glucose (mg/dL) (time frame: week 1 vs. week 4). 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 NCT03326232, which also lists 22 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 24 Nov 2017.