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

Not Applicable

Recruiting

• Conditions: Pregestational Diabetes
• Interventions: Device: CGM

• Registration Number: NCT06141941
• Lead Sponsor: Andrea L. Greiner

Brief Summary

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.

Detailed Description

This is a prospective cohort study of women with type 1 and type 2 diabetes in the postpartum period. After obtaining informed consent, a CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to labor or in prenatal clinic if seen within 3 days of planned induction of labor or planned cesarean section. Patient will be assisted in getting the Dexcom G6 app on their cell phone to be the receiver of glucose data. Patients who are currently using the Dexcom CGM for routine monitoring of their glucoses, will be allowed to continue using their own sensor and transmitter. Upon presentation to Labor and Delivery, patients will be assisted in activating the Share App on their cell phone. Labor and Delivery Nursing Staff will be given a Samsun phone with the Follow app in order to receive glucose data. The Samsung phone will be transferred to the Mother/Baby Unit with the patient after delivery.

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2023-10-23
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-01
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM	CGM	A CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to Labor and Delivery unit.

Primary Outcome Measures

Name	Time	Method
Glucose values	Postpartum admission, 2-4 days	glucose values obtained from CGM application

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States