Use of an automated insulin pump and CGM in pregnant people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-arm study, pregnant women with type 2 diabetes starting at 16 weeks gestation will use the MiniMed 780G insulin pump with continuous glucose monitoring from recruitment through delivery. Participants will have regular clinic visits for glucose data review and insulin adjustments, with outcomes including time in target glucose range (63-140 mg/dL), average glucose, HbA1c, and maternal and neonatal safety. The primary aim is to see if automated insulin delivery can improve glycemic control during pregnancy. Secondary outcomes will monitor maternal health and neonatal outcomes to ensure safety and potential benefits. All participants will use the same device throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women with diagnosed pregestational type 2 diabetes or HbA1c \>6.5% in the 1st trimester (ADA, PTD)
2. Age 18-45 years
3. Gestational age of 16 weeks +0 days or less at baseline
4. Singleton pregnancy
5. HbA1c at baseline 5.0-10%
6. A viable pregnancy at the recruitment
7. Willingness to continue the treatment until delivery in the clinic

Exclusion Criteria:

1. Other types of diabetes including T1D and Monogenic diabetes
2. Major fetal congenital defects
3. Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial
4. Pump therapy before pregnancy

Where it's running

• Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
  Poznan, Wielkopolska, Poland Recruiting

Study contacts

• Principal investigator: Ewa Wender-Ozegowska, Prof. MD PhD — Poznan University of Medical Sciences
• Study coordinator: Ewa Wender-Ozegowska, Prof. MD PhD
• Email: ewozegow@ump.edu.pl
• Phone: +48 (61) 841-93-02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.