CompletedNot Applicable

Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity

France80 participantsStarted 2025-05-15

Plain-language summary

The purpose of this observational study is to measure the association between continuous glucose monitoring (CGM) parameters and perinatal morbidity in offspring of women with type 2 diabetes. Specifically, the study will assess whether gestational age interacts with metabolic control in influencing perinatal morbidity, as well as the impact of the timing of CGM initiation during pregnancy.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient * Patient diagnosed with type 2 diabetes before or during pregnancy (fasting blood glucose \> 126 mg/dL, blood glucose \> 200 mg/dL after an oral glucose tolerance test, or HbA1c \> 6.5%) * Patient who has undergone continuous glucose monitoring at least once during pregnancy Exclusion Criteria: * Multiple pregnancy * Pregnancy terminated before 20 weeks of amenorrhea * Delivery outside CHSF * Patient and/or legal guardians of the newborn who objected to the use of data

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

time in range (63-140 mg/dL) in pourcentage

Timeframe: up to delivery

preterm birth : yes or no

Timeframe: at delivery

birth weight in kilogramme

Timeframe: at delivery

neonatal hypoglycemia : yes or no

Timeframe: at delivery

shoulder dystocia : yes or no

Timeframe: at delivery

neonatal resuscitation : yes or no

Timeframe: at delivery

perinatal mortality : yes or no

Timeframe: at delivery

Trial details

NCT IDNCT06892314

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-26

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

time in range (63-140 mg/dL) in pourcentage

Timeframe: up to delivery

preterm birth : yes or no

Timeframe: at delivery

birth weight in kilogramme

Timeframe: at delivery

neonatal hypoglycemia : yes or no

Timeframe: at delivery

shoulder dystocia : yes or no

Timeframe: at delivery

neonatal resuscitation : yes or no

Timeframe: at delivery

perinatal mortality : yes or no

Timeframe: at delivery