Does the Use of Continuous Glucose Monitoring (CGM) in the Immediate Postpartum Period in Women With Pregestational Diabetes Admitted to the Hospital Decrease Hypoglycemic Episodes
NCT ID: NCT06141941
Last Updated: 2023-11-21
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
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-06-01
2024-04-30
Brief Summary
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Detailed Description
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Glucose values from the CGM device will then be available to nursing through the Samsung phone. Nursing will be able to see current glucose data on their patient and would receive alarms to indicate hypoglycemia or impending hypoglycemia. Nursing will be provided with instructions for how to access the CGM follow app and how to appropriately respond to the alarms. Nursing will continue to perform standard of care blood glucose monitoring per routine protocol but will also obtain a finger stick to validate a blood glucose level whenever a low CGM alarm sounds. Low blood glucose values \<70 mg/dl will be treated per local institutional nursing policy. Monitoring of glucose levels through the CGM device will continue throughout their postpartum hospital stay. This is typically 2 days for a vaginal delivery, 3 days for a cesarean section. Patients who do not use CGM as part of their routine care, will have their CGM sensor and transmitter removed prior to discharge from the hospital.
Following discharge from the hospital, there will be no additional long term follow-up.
Data we plan to collect for analysis includes: type of diabetes (DM1/DM2), point of care glucose values, number of hypoglycemic events, number of times treated for hypoglycemia.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CGM
A CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to Labor and Delivery unit.
CGM
Continuous glucose monitoring
Interventions
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CGM
Continuous glucose monitoring
Eligibility Criteria
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Inclusion Criteria
Exclusion:
1. Patients less than 18 years of age
2. non-English speaking patients
3. gestational diabetes
4. extensive skin changes/diseases that inhibit wearing a sensor on normal skin, known allergy to adhesives
18 Years
50 Years
FEMALE
Yes
Sponsors
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Andrea L. Greiner
OTHER
Responsible Party
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Andrea L. Greiner
Clinical Professor
Principal Investigators
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Andrea Greiner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa OBGYN
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Spanakis EK, Levitt DL, Siddiqui T, Singh LG, Pinault L, Sorkin J, Umpierrez GE, Fink JC. The Effect of Continuous Glucose Monitoring in Preventing Inpatient Hypoglycemia in General Wards: The Glucose Telemetry System. J Diabetes Sci Technol. 2018 Jan;12(1):20-25. doi: 10.1177/1932296817748964. Epub 2017 Dec 13.
Singh LG, Satyarengga M, Marcano I, Scott WH, Pinault LF, Feng Z, Sorkin JD, Umpierrez GE, Spanakis EK. Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020 Nov;43(11):2736-2743. doi: 10.2337/dc20-0840. Epub 2020 Aug 5.
Other Identifiers
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202101006
Identifier Type: -
Identifier Source: org_study_id