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Glucose sensor compared with finger pricks in pregnant women with gestational diabetes

Compares a worn glucose sensor with finger-prick checks in pregnant women with gestational diabetes.

Key facts

Who runs it
Hospital Clinic of Barcelona
Where
Spain1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes
Status
Not yet recruiting
People taking part
100 people, planned
Started
1 Oct 2026
Expected to end
31 May 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Continuous Glucose Monitoring (FreeStyle Libre 2)
  • Self-Monitoring of Blood Glucose (Capillary Glucose Meter)
Record updated
18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women with gestational diabetes (diabetes first found in pregnancy). It compares a skin sensor that tracks blood sugar with finger-prick tests.

Age
18 years and older
Sex
Women only
Disease stage
Gestational diabetes found between 24 and 28 weeks of pregnancy. It must be confirmed by a 50 g glucose challenge test and then a 100 g oral glucose tolerance test with at least 2 abnormal values. Only one baby in the pregnancy.
Earlier treatment
You cannot join if you took metformin during this pregnancy.
Biomarker or test result
Abnormal 50 g glucose challenge test, followed by an abnormal 100 g oral glucose tolerance test with at least 2 abnormal values.

Main reasons for not taking part

  • Type 1 or type 2 diabetes from before the pregnancy
  • Past weight-loss (bariatric) surgery
  • Long-term steroid (corticosteroid) treatment
  • A reason the sensor cannot be used, such as a severe skin problem where it goes in
  • No smartphone or digital device with internet to send glucose data

This trial only enrols pregnant participants. The registry sentence this rests on: * Pregnant women aged ≥18 years

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Pregnant women aged ≥18 years
  • Singleton pregnancy
  • Diagnosis of gestational diabetes mellitus (GDM) according to local two-step protocol (abnormal 50 g glucose challenge test followed by abnormal 100 g oral glucose tolerance test with at least 2 abnormal values)
  • Gestational age between 24 and 28 weeks at time of GDM diagnosis
  • Access to a compatible smartphone or digital device with internet connection to allow synchronization and remote upload of glucose data (CGM or SMBG)
  • Ability and willingness to provide written informed consent

Who cannot take part

  • Treatment with metformin during pregnancy
  • Chronic systemic corticosteroid therapy
  • Preexisting type 1 or type 2 diabetes mellitus
  • History of bariatric surgery
  • Known contraindications to use of a CGM sensor (e.g., severe dermatologic conditions at insertion site)
  • Inability to comply with study procedures or follow-up

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Gestational diabetes mellitus (GDM) is a type of diabetes that is first diagnosed during pregnancy. It causes high blood sugar levels and can increase the risk of health problems for both the mother and the baby. Babies may grow larger than expected (macrosomia), which can make delivery more difficult and increase the risk of birth complications. Mothers with GDM are also more likely to need insulin treatment and may have a higher risk of high blood pressure during pregnancy. Good blood sugar control is important to reduce these risks.

Read full original descriptionShow less

The usual way to monitor blood sugar in women with GDM is by self-monitoring of blood glucose (SMBG). This involves pricking the finger several times a day to measure blood sugar levels. Although this method provides useful information, it only shows glucose levels at specific moments and may miss changes that happen during the night or between measurements.

Continuous glucose monitoring (CGM) is a newer method that uses a small sensor placed under the skin to measure glucose levels throughout the day and night. It provides more detailed information about blood sugar patterns and does not require frequent finger pricks. CGM has been shown to improve blood sugar control in people with type 1 and type 2 diabetes, but its benefits in women with gestational diabetes are not yet fully known.

The purpose of this study is to compare continuous glucose monitoring (CGM) with standard finger-prick monitoring (SMBG) in pregnant women diagnosed with gestational diabetes between 24 and 28 weeks of pregnancy. The study will evaluate whether CGM is practical to use, whether women are satisfied with it, and whether it may help improve blood sugar control and pregnancy outcomes.

A total of 100 pregnant women with gestational diabetes will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:

One group will use a continuous glucose monitoring device.

The other group will continue with standard finger-prick blood glucose monitoring.

Both groups will receive the same medical care, including dietary advice, physical activity recommendations, and insulin treatment if needed. Participants will attend regular pregnancy visits every 2 to 3 weeks until delivery, as part of usual care. No extra hospital visits are required because of the study. Women using CGM will receive training on how to use the device.

The researchers will compare blood sugar control, the need for insulin, pregnancy complications, and newborn outcomes such as birth weight and episodes of low blood sugar after birth. The study will also assess how satisfied women are with their glucose monitoring method and how it affects their quality of life.

This is a pilot study, which means its main goal is to determine whether a larger study should be carried out in the future. The results will help researchers understand whether continuous glucose monitoring could improve the care of women with gestational diabetes and their babies.

The 2 groups in the trial

  • Continuous Glucose Monitoring (CGM)Treatment being tested

    Participants randomized to this arm will use a real-time continuous glucose monitoring system (FreeStyle Libre 2) from randomization (24-28 weeks of gestation) until delivery. The sensor will be placed by trained staff, and participants will receive standardized training on device use and interpretation of glucose trends. Clinical decisions, including dietary adjustments and initiation or titration of insulin therapy, will be based on CGM data according to local gestational diabetes protocols. A capillary glucose meter will be provided for confirmatory measurements if needed. All other aspects of care will follow standard practice.

    Treatment: Continuous Glucose Monitoring (FreeStyle Libre 2)

  • Self-Monitoring of Blood Glucose (SMBG)Existing treatment, for comparison

    Participants randomized to this arm will perform standard self-monitoring of blood glucose using capillary finger-prick measurements (typically fasting and postprandial values, 4-6 times daily) from randomization until delivery. Participants will receive standardized education on measurement technique and recording. Clinical decisions, including dietary adjustments and insulin initiation or titration, will be based on SMBG values according to local gestational diabetes protocols. All other aspects of care, including obstetric follow-up, will follow standard clinical practice.

    Treatment: Self-Monitoring of Blood Glucose (Capillary Glucose Meter)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes: A Pilot Randomized Clinical Trial
Plain-language title
Glucose sensor compared with finger pricks in pregnant women with gestational diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
18 September 2026