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

November 20, 2023 updated by: Andrea L. Greiner
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CGM
A CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to Labor and Delivery unit.
Device: CGM
Continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose values
Time Frame: Postpartum admission, 2-4 days
glucose values obtained from CGM application
Postpartum admission, 2-4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea L. Greiner

Investigators

  • Principal Investigator: Andrea Greiner, MD, University of Iowa OBGYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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