NCT06141941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

October 23, 2023

Results QC Date

April 23, 2025

Last Update Submit

March 30, 2026

Conditions

Pregestational Diabetes

Keywords

postpartumtype 1 diabetestype 2 diabetescontinuous glucose monitor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Hypoglycemia During Postpartum Hospital Stay

    glucose values

    Postpartum admission, 2-5 days

Study Arms (2)

CGM

EXPERIMENTAL

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

Device: CGM

Standard glucometer

ACTIVE COMPARATOR
Device: CGM

Interventions

CGMDEVICE

Continuous glucose monitoring

CGMStandard glucometer

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

  • 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.

    PMID: 28923465BACKGROUND

  • 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.

    PMID: 29237288BACKGROUND

  • 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.

    PMID: 32759361BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Andrea Greiner, MD
Organization
Univ of Iowa, Department of OBGYN
andrea-greiner@uiowa.edu
3193563180

Study Officials

  • Andrea Greiner, MD

    University of Iowa OBGYN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 21, 2023

Study Start

June 1, 2021

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 9, 2026

Results First Posted

April 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)