Type 2 Diabetes and Pregnancy a Single-arm Interventional Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPoznan University of Medical Sciences
About this trial
This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments. The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg/dL). Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.
Eligibility criteria
Qualifiers
Women with diagnosed pregestational type 2 diabetes or HbA1c >6.5% in the 1st trimester (ADA, PTD)
Age 18-45 years
Gestational age of 16 weeks +0 days or less at baseline
Singleton pregnancy
Disqualifiers
Other types of diabetes including T1D and Monogenic diabetes
Major fetal congenital defects
Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial
Pump therapy before pregnancy
Trial design
Treatments tested in this trial
- Automated insulin delivery system - Medtronic 780G
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Poznan University of Medical Sciences
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov