Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04605497

Enrollment

111

Registered

2020-10-28

Start date

2021-02-11

Completion date

2023-12-31

Last updated

2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Female, pregnancy, gestational diabetes

Brief summary

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

Interventions

DIAGNOSTIC_TESTContinuous glucose monitoring (CGM)

Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period

DIAGNOSTIC_TESTSelf-Capillary Blood Glucose Monitoring (SCBG)

Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Age 18-55 years * Singleton pregnancy ≥20 weeks gestation * Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan) * Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver

Exclusion criteria

* Chronic immunosuppression * Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder * Known allergy to medical grade adhesives * Pre-gestational diabetes * Multifetal gestation * Current alcohol or illicit drug use * Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Design outcomes

Primary

Measure	Time frame
Average time-in-range over a 24 hour period	From enrollment to10 days after discharge from hospital following delivery

Secondary

Measure	Time frame
Average time-in-range during waking hours	From enrollment to10 days after discharge from hospital following delivery
Average time-in-range while asleep	From enrollment to10 days after discharge from hospital following delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026