Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)
15 maja 2026 zaktualizowane przez: Poznan University of Medical Sciences
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.
This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.
Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.
The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.
This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.
This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.
Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.
The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ewa Wender-Ozegowska, Prof. MD PhD
- Numer telefonu: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
Lokalizacje studiów
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polska, 60-535
- Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
-
Kontakt:
- Ewa Wender-Ozegowska, Prof. MD PhD
- Numer telefonu: +48 (61) 841-93-02
- E-mail: ewozegow@ump.edu.pl
-
Główny śledczy:
- Ewa Wender-Ozegowska, Prof. MD PhD
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- 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
- HbA1c at baseline 5.0-10%
- A viable pregnancy at the recruitment
- Willingness to continue the treatment until delivery in the clinic
Exclusion Criteria:
- 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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Type 2 diabetes
Pregnant patients with type 2 diabetes treated with automated insulin delivery system
|
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time in range
Ramy czasowe: From enrollment to the delivery
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
From enrollment to the delivery
|
|
Mean sensor glycemia
Ramy czasowe: From enrollment to the delivery
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
From enrollment to the delivery
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time in range
Ramy czasowe: Week 18
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 18
|
|
Time in range
Ramy czasowe: Week 22
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 22
|
|
Time in range
Ramy czasowe: Week 26
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 26
|
|
Time in range
Ramy czasowe: Week 30
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 30
|
|
Time in range
Ramy czasowe: Week 34
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 34
|
|
Time in range
Ramy czasowe: Week 37
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 37
|
|
Time in tight range
Ramy czasowe: Week 18
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 18
|
|
Time in tight range
Ramy czasowe: Week 22
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 22
|
|
Time in tight range
Ramy czasowe: Week 26
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 26
|
|
Time in tight range
Ramy czasowe: Week 30
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 30
|
|
Time in tight range
Ramy czasowe: Week 34
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 34
|
|
Time in tight range
Ramy czasowe: Week 37
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 37
|
|
Change in the time in range values
Ramy czasowe: From the recruitment to delivery
|
Change in percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
From the recruitment to delivery
|
|
Time above range
Ramy czasowe: Week 18
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 18
|
|
Time above range
Ramy czasowe: Week 22
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 22
|
|
Time above range
Ramy czasowe: Week 26
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 26
|
|
Time above range
Ramy czasowe: Week 30
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 30
|
|
Time above range
Ramy czasowe: Week 34
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 34
|
|
Time above range
Ramy czasowe: Week 37
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 37
|
|
Time above tight range
Ramy czasowe: Week 18
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 18
|
|
Time above tight range
Ramy czasowe: Week 22
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 22
|
|
Time above tight range
Ramy czasowe: Week 26
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 26
|
|
Time above tight range
Ramy czasowe: Week 30
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 30
|
|
Time above tight range
Ramy czasowe: Week 34
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 34
|
|
Time above tight range
Ramy czasowe: Week 37
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 37
|
|
Time below range
Ramy czasowe: Week 18
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 18
|
|
Time below range
Ramy czasowe: Week 22
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 22
|
|
Time below range
Ramy czasowe: Week 26
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 26
|
|
Time below range
Ramy czasowe: Week 30
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 30
|
|
Time below range
Ramy czasowe: Week 34
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 34
|
|
Time below range
Ramy czasowe: Week 37
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 37
|
|
Mean sensor glycemia
Ramy czasowe: Week 18
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Mean sensor glycemia
Ramy czasowe: Week 22
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Mean sensor glycemia
Ramy czasowe: Week 26
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Mean sensor glycemia
Ramy czasowe: Week 30
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Mean sensor glycemia
Ramy czasowe: Week 34
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Mean sensor glycemia
Ramy czasowe: Week 37
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 18
|
Metric of glycemic variability measured by the sensor (%)
|
Week 18
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 22
|
Metric of glycemic variability measured by the sensor (%)
|
Week 22
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 26
|
Metric of glycemic variability measured by the sensor (%)
|
Week 26
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 30
|
Metric of glycemic variability measured by the sensor (%)
|
Week 30
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 34
|
Metric of glycemic variability measured by the sensor (%)
|
Week 34
|
|
Coefficient of variation (%CV)
Ramy czasowe: Week 37
|
Metric of glycemic variability measured by the sensor (%)
|
Week 37
|
|
Standard deviation (SD)
Ramy czasowe: Week 18
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Standard deviation (SD)
Ramy czasowe: Week 22
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Standard deviation (SD)
Ramy czasowe: Week 26
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Standard deviation (SD)
Ramy czasowe: Week 30
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Standard deviation (SD)
Ramy czasowe: Week 34
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Standard deviation (SD)
Ramy czasowe: Week 37
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
HbA1C
Ramy czasowe: Week 18
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 18
|
|
HbA1C
Ramy czasowe: Week 22
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 22
|
|
HbA1C
Ramy czasowe: Week 26
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 26
|
|
HbA1C
Ramy czasowe: Week 30
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 30
|
|
HbA1C
Ramy czasowe: Week 34
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 34
|
|
HbA1C
Ramy czasowe: Week 37
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 37
|
|
Severe hypoglycemia episodes
Ramy czasowe: From recruitment until delivery.
|
Number of episodes of self-reported severe hypoglycemia.
|
From recruitment until delivery.
|
|
Gestational weight gain
Ramy czasowe: From recruitment until delivery
|
Maternal gestational weight gain (kg)
|
From recruitment until delivery
|
|
Gestational weight gain from pre-pregnancy
Ramy czasowe: From pre-pregnancy until delivery
|
Self-reported maternal gestational weight gain (kg)
|
From pre-pregnancy until delivery
|
|
Pregnancy hypertensive disorders
Ramy czasowe: From recruitment until delivery
|
Preeclampsia, Eclampsia, Gestational hypertension
|
From recruitment until delivery
|
|
The mode of delivery
Ramy czasowe: At delivery
|
Vaginal, c-section, spontaneous, induction of labor
|
At delivery
|
|
Birth trauma
Ramy czasowe: At delivery
|
IADPSG criteria
|
At delivery
|
|
Gestational birth weight
Ramy czasowe: At delivery
|
Neonatal birth weight in grams
|
At delivery
|
|
Macrosomia
Ramy czasowe: At delivery
|
Gestational birth weight >4200g
|
At delivery
|
|
Large-for-gestational-age (LGA)
Ramy czasowe: At delivery
|
Neonatal birth weight >90th percentile
|
At delivery
|
|
Small-for-gestational-age (SGA)
Ramy czasowe: At delivery
|
Neonatal birth weight >10th percentile
|
At delivery
|
|
Placental weight
Ramy czasowe: At delivery
|
Measured in grams
|
At delivery
|
|
Gestational age
Ramy czasowe: At delivery
|
Timing of delivery
|
At delivery
|
|
Preterm birth
Ramy czasowe: At delivery
|
<37 weeks
|
At delivery
|
|
Number of neonates with respiratory distress syndrome
Ramy czasowe: From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
Defined as the number of neonates diagnosed with respiratory distress syndrome during the postnatal hospital stay, based on clinical signs of respiratory distress and the need for respiratory support, with or without radiological confirmation, according to local neonatal clinical practice.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with jaundice requiring phototherapy
Ramy czasowe: From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
Defined as the number of neonates diagnosed with neonatal jaundice requiring phototherapy during the postnatal hospital stay.
Phototherapy requirement will be determined according to local neonatal clinical practice based on serum or transcutaneous bilirubin assessment.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with neonatal hypoglycemia
Ramy czasowe: Assessed from delivery until 24 hours postpartum
|
Neonatal hypoglycemia - glucose concentrations in neonatal blood <40 mg/dL (2.2 mmol/L) in a single laboratory measurement at least 3 hours after birth, in the first 24 hours of life
|
Assessed from delivery until 24 hours postpartum
|
|
Stillbirth
Ramy czasowe: From week 22
|
Pregnancy loss after 22 weeks
|
From week 22
|
|
Neonatal length of hospital stay
Ramy czasowe: From date of delivery until the date of hospital discharge, assessed up to 20 weeks
|
Duration of neonatal hospitalization, measured in days
|
From date of delivery until the date of hospital discharge, assessed up to 20 weeks
|
|
Length of stay in the neonatal intensive care unit (NICU)
Ramy czasowe: From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
|
Duration of NICU stay, measured in days
|
From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
|
|
Neonatal acidosis
Ramy czasowe: At delivery
|
Umbilical pH <7.15
|
At delivery
|
|
Apgar score
Ramy czasowe: At delivery
|
Apgar score <8
|
At delivery
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Ewa Wender-Ozegowska, Prof. MD PhD, Poznan University of Medical Sciences
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Gladych-Macioszek A, Mantaj U, Tobola-Wrobel K, Radzicka-Mularczyk S, Sibiak R, Adamczak L, Desoye G, Wender-Ozegowska E. Early gestational diabetes mellitus and type 2 diabetes: do they differ in perinatal outcome- a retrospective analysis. BMC Pregnancy Childbirth. 2026 Mar 11;26(1):423. doi: 10.1186/s12884-026-08927-3.
- Sibiak R, Iciek R, Gastolek K, Chudzynska E, Meek C, Wender-Ozegowska E. Ten-year national trends in the prevalence and outcomes of gestational diabetes mellitus in Poland: a population-based study. Pol Arch Intern Med. 2026 Feb 26;136(2):17202. doi: 10.20452/pamw.17202. Epub 2026 Jan 19.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 maja 2026
Zakończenie podstawowe (Szacowany)
1 października 2028
Ukończenie studiów (Szacowany)
1 lutego 2029
Daty rejestracji na studia
Pierwszy przesłany
6 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
15 maja 2026
Pierwszy wysłany (Rzeczywisty)
22 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
15 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 599_25
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
produkt wyprodukowany i wyeksportowany z USA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .