Pregestational Diabetes Clinical Trial
Official title:
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 number | NCT06141941 |
Other study ID # | 202101006 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | April 2024 |
This study will examine whether continuous glucose monitoring in patients hospitalized in the immediate postpartum period is more effective than traditional point of care glucose testing in identifying patients with hypoglycemia.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion: 1- Individuals in the third trimester of pregnancy admitted to the hospital with diabetes type 1 or diabetes type 2, own a smart device (which will serve as a receiver for the CGM device) 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Andrea L. Greiner |
United States,
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. Erratum In: Lancet. 2017 Nov 25;390(10110):2346. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose values | glucose values obtained from CGM application | Postpartum admission, 2-4 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05553275 -
Permissive Intrapartum Glucose Control
|
N/A | |
Completed |
NCT03504592 -
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
|
N/A | |
Completed |
NCT02793505 -
Safety of Metformin in Pregnancy
|
N/A | |
Not yet recruiting |
NCT05152589 -
Maternal Diabetes in Newborns With Hearing Loss
|
||
Not yet recruiting |
NCT01255384 -
Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes
|
N/A | |
Not yet recruiting |
NCT01158040 -
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
|
N/A |