No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Thomas Jefferson University · Other
Who this trial is looking for
This trial is looking for pregnant women with type 2 diabetes. Participants will use either a fingerstick method or a continuous glucose monitor to check their blood sugar levels during pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I have a singleton pregnancy
My fetus has no anomalies
I have been diagnosed with type 2 diabetes
I started prenatal care before 20 weeks of pregnancy
You may not be able to join if
I have been diagnosed with type 1 diabetes
I am allergic to insulin
I cannot wear a continuous glucose monitor
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby insi…
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements.
Patients involved in the study will be assigned to either:
1. Fingerstick glucose monitoring (FSG)
2. Continuous glucose monitoring (CGM)
Patients will be randomize in a 1:1 ratio.
FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery.
CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days.
Percent adherence will be recorded from the time you were randomized to a study group until delivery.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* singleton pregnancies
* fetuses without anomalies
* diagnosis of Type 2 diabetes
* initiation of prenatal care at \<20 weeks gestation
Exclusion Criteria:
* diagnosis of Type 1 diabetes
* allergy to insulin
* inability to wear a continuous glucose monitor
Inclusion Criteria:
* singleton pregnancies
* fetuses without anomalies
* diagnosis of Type 2 diabetes
* initiation of prenatal care at \<20 weeks gestation
Exclusion Criteria:
* diagnosis of Type 1 diabetes
* allergy to insulin
* inability to wear a continuous glucose monitor
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