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CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how well pregnant patients keep track of blood sugar using finger-stick tests or a continuous monitor, which uses a sensor on the arm. It is for patients who had type 2 diabetes before pregnancy. Patients are assigned by chance to one of the two methods and use it until delivery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant with one baby.
  • The baby has no birth defects.
  • Have type 2 diabetes.
  • Started pregnancy care before 20 weeks of pregnancy.

Who can't join

  • Have type 1 diabetes.
  • Are allergic to insulin.
  • Cannot wear a continuous blood sugar monitor.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

NJ

PA