Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
21 participants
OBSERVATIONAL
2019-08-20
2022-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary Objective: To compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum.
Design and Project Type Prospective cohort study. Women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 DM done 24 hours after delivery. They will also have routine screening for type 2 DM done at 6-12 weeks postpartum.
Description of Intervention The intervention is early screening for type 2 DM which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement.
Instruments Fingerstick testing will be done with StatStrip Glucose Hospital Meter (Nova Biomedical). This device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. Using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Blood Glucose Test - 2hour GTT
Only one arm: intervention group. The intervention is fasting 2 hour glucose tolerance test in the immediate postpartum period. The screening test consists of fingerstick blood glucose testing after a glucose drink. First, a fasting blood glucose finger stick will be performed. Second, the glucose drink is orally ingested containing 75g glucose. The drink is to be orally ingested over 60 seconds. Lastly, fingerstick blood glucose testing is completed at 1 hour post drink and 2 hours post drink.
2 hour glucose tolerance test using 75g glucose drink
intervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2 hour glucose tolerance test using 75g glucose drink
intervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>18 years-old (yo)yo,
* English speaking.
Exclusion Criteria
* did not require anti-hyperglycemic medication therapy (GDMA1),
* early onset GDM (\<20 weeks).
* do not speak English .
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Banner University Medical Center
OTHER
Pediatrix
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Wilkes
Role: STUDY_DIRECTOR
Banner University Medical Center
Kisti Fuller, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Perinatal Associates, Mednax
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gobl CS, Bozkurt L, Prikoszovich T, Winzer C, Pacini G, Kautzky-Willer A. Early possible risk factors for overt diabetes after gestational diabetes mellitus. Obstet Gynecol. 2011 Jul;118(1):71-78. doi: 10.1097/AOG.0b013e318220e18f.
Su X, Zhang Z, Qu X, Tian Y, Zhang G. Hemoglobin A1c for diagnosis of postpartum abnormal glucose tolerance among women with gestational diabetes mellitus: diagnostic meta-analysis. PLoS One. 2014 Jul 11;9(7):e102144. doi: 10.1371/journal.pone.0102144. eCollection 2014.
Mendez-Figueroa H, Daley J, Breault P, Lopes VV, Paine V, Goldman D, Francis MJ, Delgado B, Coustan DR. Impact of an intensive follow-up program on the postpartum glucose tolerance testing rate. Arch Gynecol Obstet. 2014 Jun;289(6):1177-83. doi: 10.1007/s00404-014-3157-0. Epub 2014 Jan 31.
Kjos SL, Peters RK, Xiang A, Henry OA, Montoro M, Buchanan TA. Predicting future diabetes in Latino women with gestational diabetes. Utility of early postpartum glucose tolerance testing. Diabetes. 1995 May;44(5):586-91. doi: 10.2337/diab.44.5.586.
5. Biljok VR, Bozicevic S, Lovrencic MV, Car N. Performance of the StatStrip Glucose Meter in Inpatient Management of Diabetes Mellitus. Diabetologia Croatica 2010; 39-3:105-109.
Werner EF, Has P, Tarabulsi G, Lee J, Satin A. Early Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2016 Aug;33(10):966-71. doi: 10.1055/s-0036-1583193. Epub 2016 Apr 27.
Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.
Vucic Lovrencic M, Radisic Biljak V, Bozicevic S, Pape-Medvidovic E, Ljubic S. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. Int J Endocrinol. 2013;2013:206309. doi: 10.1155/2013/206309. Epub 2013 Dec 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GDM 2019 iris 01-18-0028
Identifier Type: -
Identifier Source: org_study_id