Health TrialsbyHealthPanel

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

ConditionsGestational DiabetesHyperglycemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorOhio State University

About this trial

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women with a viable singleton intrauterine pregnancy

Able to understand the study, and having understood, provide written informed consent in English

Recent pregnancy affected by gestational diabetes

Disqualifiers

Pregestational Diabetes (Type I or Type II)

Continued use of diabetes medications (including metformin and insulin) immediately after delivery

Preterm delivery (< 37 weeks gestation)

Twin or higher order gestation

Trial population

We anticipate enrolling a total of 20 participants with a recent pregnancy affected by GDM

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continuous glucose monitor

    Device

    CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.

  • Oral Glucose Tolerance Test

    Diagnostic test

    At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times.

  • Hemoglobin A1c

    Diagnostic test

    At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Participants3 interventions

Trial outcomes

Primary outcomes

1

Acceptability of CGM

As determined by survey

Time frame
15 weeks from enrollment
2

Comparative experience of OGTT and CGM

As determined by survey

Time frame
15 weeks from enrollment

Secondary outcomes

1

Prevalence and characteristics of dysglycemia in GDM postpartum

As determined by survey

Time frame
15 weeks from enrollment
2

Lifestyle changes survey

Breastfeeding practices, changes in diet and physical activity

Time frame
15 weeks from enrollment
3

Medical care

Number of doctor's visits (both for participant and their infant), prescribed medications

Time frame
15 weeks from enrollment

Other outcomes

1

Infant outcomes

in-hospital medical record review

Time frame
birth outcomes only

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

DexCom, Inc.

Collaborator

Source ClinicalTrials.gov
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