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OpenTrials
Completed

NCT Number: NCT06141941

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Patients less than 18 years of age
  • non-English speaking patients
  • gestational diabetes
  • extensive skin changes/diseases that inhibit wearing a sensor on normal skin, known allergy to adhesives

Treatment and study plan

CGM

Device

Continuous glucose monitoring

Primary outcomes

  1. Number of Participants With Hypoglycemia During Postpartum Hospital Stay

    Time frame: Postpartum admission, 2-5 days

    glucose values

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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